NDC properties for "brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Solution" (RxCUI 861635)
About this data
The tables show NDC propoerties for brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Solution with the RxCUI 861635
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product
Details for brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Solution (RxCUI 861635)
| ANDA | ANDA091087 |
|---|---|
| ANDA | ANDA091442 |
| ANDA | ANDA201949 |
| ANDA | ANDA214987 |
| ANDA | ANDA215230 |
| ANDA | ANDA215598 |
| ANDA | ANDA216114 |
| ANDA | ANDA217288 |
| ANDA | ANDA219093 |
| MMSL_CODE | BD12362 |
| MMSL_CODE | CD12362 |
| RxCUI | 861635 |
| SNOMEDCT | 784822005 |
| SPL_SET_ID | 09476aab-0816-812c-e063-6394a90a12a2 |
| SPL_SET_ID | 10e79593-b991-4899-89fd-6fff7a213d81 |
| SPL_SET_ID | 268c3f6b-8798-7987-3b8c-7b7f560af5d7 |
| SPL_SET_ID | 7011a203-46cf-434d-ba11-253f107ff80f |
| SPL_SET_ID | 71e50a17-54dd-4d08-b5ae-b5f46e38b3e1 |
| SPL_SET_ID | 744e10e6-c477-4a4b-b608-1193bd43f112 |
| SPL_SET_ID | 8b13bd5a-b65f-4e39-83f1-8d3abe97d4c0 |
| SPL_SET_ID | af21d2e5-0029-4889-ba93-6417baa91ce6 |
| SPL_SET_ID | b54e5bee-2329-4cc2-bed1-8eef11ee488c |
| SPL_SET_ID | b5d560b6-847e-4f09-b1ef-22e4deb8a206 |
| SPL_SET_ID | bf6a7f59-5a10-49fe-9e57-19e3ba202918 |
| SPL_SET_ID | e4fdbd17-73b7-49ed-9de3-591f36e0645d |
| SPL_SET_ID | eac3cec2-b373-4936-89f0-c6d300e09f6e |
| VUID | 4027224 |
| Prescribable Synonym | brimonidine tartrate 0.2 % / timolol maleate 0.5 % Ophthalmic Solution |
| RXNAV_STR | brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic Solution |
| RxNorm Name | brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic Solution |
| RxNorm Synonym | brimonidine tartrate 0.2 % / timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Solution |
| Related queries | Interactions (for RxCUI 861635) |
NDC Properties
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 00591242212
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-12 |
| NDC Item | 00591242212 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242226
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-26 |
| NDC Item | 00591242226 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-26) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00591242279
| NDC 9 | 0591-2422 |
|---|---|
| NDC 10 | 0591-2422-79 |
| NDC Item | 00591242279 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 789463 |
| Labeler | Actavis Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-11-30 |
| Marketing effective time low | 2022-10-07 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 0591-2422 |
NDC Item 00781718670
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-70 |
| NDC Item | 00781718670 |
| Packaging | 10 mL in 1 BOTTLE, DROPPER (0781-7186-70) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718675
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-75 |
| NDC Item | 00781718675 |
| Packaging | 5 mL in 1 BOTTLE, DROPPER (0781-7186-75) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00781718685
| NDC 9 | 0781-7186 |
|---|---|
| NDC 10 | 0781-7186-85 |
| NDC Item | 00781718685 |
| Packaging | 15 mL in 1 BOTTLE, DROPPER (0781-7186-85) |
| ANDA | ANDA091087 |
| FDA SPL set id | 813305 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-04-13 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0781-7186 |
NDC Item 00832142505
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-05 |
| NDC Item | 00832142505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142510
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-10 |
| NDC Item | 00832142510 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 00832142515
| NDC 9 | 0832-1425 |
|---|---|
| NDC 10 | 0832-1425-15 |
| NDC Item | 00832142515 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0832-1425-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215598 |
| FDA SPL set id | 828825 |
| Labeler | Upsher-Smith Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-12-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0832-1425 |
NDC Item 46708070605
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-05 |
| NDC Item | 46708070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070610
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-10 |
| NDC Item | 46708070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 46708070615
| NDC 9 | 46708-706 |
|---|---|
| NDC 10 | 46708-706-15 |
| NDC Item | 46708070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 726896 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 46708-706 |
NDC Item 60219206703
| NDC 9 | 60219-2067 |
|---|---|
| NDC 10 | 60219-2067-3 |
| NDC Item | 60219206703 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2067 |
NDC Item 60219206806
| NDC 9 | 60219-2068 |
|---|---|
| NDC 10 | 60219-2068-6 |
| NDC Item | 60219206806 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2068 |
NDC Item 60219213808
| NDC 9 | 60219-2138 |
|---|---|
| NDC 10 | 60219-2138-8 |
| NDC Item | 60219213808 |
| Packaging | 1 BOTTLE in 1 CARTON (60219-2138-8) / 15 mL in 1 BOTTLE |
| ANDA | ANDA217288 |
| FDA SPL set id | 848906 |
| Labeler | Amneal Pharmaceuticals NY LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-01-02 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60219-2138 |
NDC Item 60505058901
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-1 |
| NDC Item | 60505058901 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058902
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-2 |
| NDC Item | 60505058902 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505058903
| NDC 9 | 60505-0589 |
|---|---|
| NDC 10 | 60505-0589-3 |
| NDC Item | 60505058903 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 810827 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 60505-0589 |
NDC Item 60505622500
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-0 |
| NDC Item | 60505622500 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622501
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-1 |
| NDC Item | 60505622501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) / 10 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 60505622502
| NDC 9 | 60505-6225 |
|---|---|
| NDC 10 | 60505-6225-2 |
| NDC Item | 60505622502 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) / 15 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 747007 |
| Labeler | Apotex Corp. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2024-12-31 |
| Marketing effective time low | 2022-01-19 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 60505-6225 |
NDC Item 62332070605
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-05 |
| NDC Item | 62332070605 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070610
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-10 |
| NDC Item | 62332070610 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 62332070615
| NDC 9 | 62332-706 |
|---|---|
| NDC 10 | 62332-706-15 |
| NDC Item | 62332070615 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (62332-706-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA215230 |
| FDA SPL set id | 860628 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-08-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 62332-706 |
NDC Item 65145016201
| NDC 9 | 65145-162 |
|---|---|
| NDC 10 | 65145-162-01 |
| NDC Item | 65145016201 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-162 |
NDC Item 65145016301
| NDC 9 | 65145-163 |
|---|---|
| NDC 10 | 65145-163-01 |
| NDC Item | 65145016301 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-163 |
NDC Item 65145016401
| NDC 9 | 65145-164 |
|---|---|
| NDC 10 | 65145-164-01 |
| NDC Item | 65145016401 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (65145-164-01) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA219093 |
| FDA SPL set id | 864289 |
| Labeler | Caplin Steriles Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-03-10 |
| Marketing status | active |
| Related queries | Properties for NDC 9 65145-164 |
NDC Item 68462028132
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-32 |
| NDC Item | 68462028132 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 68462028169
| NDC 9 | 68462-281 |
|---|---|
| NDC 10 | 68462-281-69 |
| NDC Item | 68462028169 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA214987 |
| FDA SPL set id | 786892 |
| Labeler | Glenmark Pharmaceuticals Inc., USA |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-05-16 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68462-281 |
NDC Item 70069065101
| NDC 9 | 70069-651 |
|---|---|
| NDC 10 | 70069-651-01 |
| NDC Item | 70069065101 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-651 |
NDC Item 70069065201
| NDC 9 | 70069-652 |
|---|---|
| NDC 10 | 70069-652-01 |
| NDC Item | 70069065201 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-652 |
NDC Item 70069065301
| NDC 9 | 70069-653 |
|---|---|
| NDC 10 | 70069-653-01 |
| NDC Item | 70069065301 |
| Packaging | 1 BOTTLE in 1 CARTON (70069-653-01) / 15 mL in 1 BOTTLE |
| ANDA | ANDA216114 |
| FDA SPL set id | 817854 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-10-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-653 |
NDC Item 71921018805
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-05 |
| NDC Item | 71921018805 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018810
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-10 |
| NDC Item | 71921018810 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 71921018815
| NDC 9 | 71921-188 |
|---|---|
| NDC 10 | 71921-188-15 |
| NDC Item | 71921018815 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71921-188-15) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 749292 |
| Labeler | Florida Pharmaceutical Products, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-23 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71921-188 |
NDC Item 72162209602
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-2 |
| NDC Item | 72162209602 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-2) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209604
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-4 |
| NDC Item | 72162209604 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-4) / 15 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72162209607
| NDC 9 | 72162-2096 |
|---|---|
| NDC 10 | 72162-2096-7 |
| NDC Item | 72162209607 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72162-2096-7) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA091442 |
| FDA SPL set id | 818243 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2022-10-19 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72162-2096 |
NDC Item 72485063405
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-05 |
| NDC Item | 72485063405 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-05) / 5 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 72485063410
| NDC 9 | 72485-634 |
|---|---|
| NDC 10 | 72485-634-10 |
| NDC Item | 72485063410 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (72485-634-10) / 10 mL in 1 BOTTLE, DROPPER |
| ANDA | ANDA201949 |
| FDA SPL set id | 742710 |
| Labeler | ARMAS PHARMACEUTICALS INC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-11-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72485-634 |
NDC Item 82182045505
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-05 |
| NDC Item | 82182045505 |
| Packaging | 5 mL in 1 BOTTLE, PLASTIC (82182-455-05) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045510
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-10 |
| NDC Item | 82182045510 |
| Packaging | 10 mL in 1 BOTTLE, PLASTIC (82182-455-10) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |
NDC Item 82182045515
| NDC 9 | 82182-455 |
|---|---|
| NDC 10 | 82182-455-15 |
| NDC Item | 82182045515 |
| Packaging | 15 mL in 1 BOTTLE, PLASTIC (82182-455-15) |
| FDA SPL set id | 801120 |
| Labeler | Pacific Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time low | 2022-10-21 |
| Marketing status | ACTIVE |
| NDA_AUTHORIZED_GENERIC | NDA021398 |
| Related queries | Properties for NDC 9 82182-455 |