NDC properties for "TSPA 15 MG Injection" (RxCUI 1660009)
About this data
The tables show NDC propoerties for TSPA 15 MG Injection with the RxCUI 1660009
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 TSPA 15 MG Injection (RxCUI 1660009)
| ANDA | ANDA075547 |
|---|---|
| ANDA | ANDA208242 |
| ANDA | ANDA209150 |
| ANDA | ANDA210337 |
| ANDA | ANDA211831 |
| ANDA | ANDA213049 |
| ANDA | ANDA214222 |
| ANDA | ANDA216037 |
| MMSL_CODE | BD3290 |
| MMSL_CODE | CD3290 |
| RxCUI | 1660009 |
| SNOMEDCT | 1254813001 |
| SNOMEDCT | 1254814007 |
| SNOMEDCT | 326773008 |
| SPL_SET_ID | 0def6a5e-4bf5-b1fd-47b7-0f17ecfd9bc2 |
| SPL_SET_ID | 448c29f1-6d9c-4f8e-8a69-9b85e973e728 |
| SPL_SET_ID | 4b4725eb-95f1-45cc-852f-152beb5f1e2c |
| SPL_SET_ID | 69b6261a-f39d-475e-9613-1607dbbc956f |
| SPL_SET_ID | 6cb2e63c-1180-4201-b596-233d1b1a5dc8 |
| SPL_SET_ID | 6cd6ae89-c553-4328-9262-4363610a1f19 |
| SPL_SET_ID | 6dc898dc-5949-4aa4-83f8-4bd20c29eb93 |
| SPL_SET_ID | 7f931b7f-207b-4160-a784-984e5280546f |
| SPL_SET_ID | b19b03db-471d-4ee7-b1b8-6eccc39c41b0 |
| SPL_SET_ID | b702dcc9-dd0e-4386-b1e2-f20562fd2ad9 |
| VUID | 4002764 |
| Prescribable Synonym | thiotepa 15 MG Injection |
| RXNAV_STR | thiotepa 15 MG Injection |
| RxNorm Name | thiotepa 15 MG Injection |
| RxNorm Synonym | TSPA 15 MG Injection |
| Related queries | Interactions (for RxCUI 1660009) |
NDC Properties
NDC Item 00143930901
| NDC 9 | 0143-9309 |
|---|---|
| NDC 10 | 0143-9309-01 |
| NDC Item | 00143930901 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 711646 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9309 |
NDC Item 00143956501
| NDC 9 | 0143-9565 |
|---|---|
| NDC 10 | 0143-9565-01 |
| NDC Item | 00143956501 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 598405 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9565 |
NDC Item 25021024602
| NDC 9 | 25021-246 |
|---|---|
| NDC 10 | 25021-246-02 |
| NDC Item | 25021024602 |
| Packaging | 1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIAL |
| ANDA | ANDA209150 |
| FDA SPL set id | 581120 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-246 |
NDC Item 43598065011
| NDC 9 | 43598-650 |
|---|---|
| NDC 10 | 43598-650-11 |
| NDC Item | 43598065011 |
| Packaging | 1 VIAL in 1 CARTON (43598-650-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA210337 |
| FDA SPL set id | 800887 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-05-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-650 |
NDC Item 54879001413
| NDC 9 | 54879-014 |
|---|---|
| NDC 10 | 54879-014-13 |
| NDC Item | 54879001413 |
| Packaging | 15 mg in 1 VIAL, SINGLE-USE (54879-014-13) |
| ANDA | ANDA208242 |
| FDA SPL set id | 670479 |
| Labeler | STI Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2016-10-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 54879-014 |
NDC Item 68083044601
| NDC 9 | 68083-446 |
|---|---|
| NDC 10 | 68083-446-01 |
| NDC Item | 68083044601 |
| Packaging | 1 VIAL in 1 CARTON (68083-446-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-03-08 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-446 |
NDC Item 69539012301
| NDC 9 | 69539-123 |
|---|---|
| NDC 10 | 69539-123-01 |
| NDC Item | 69539012301 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-123-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-123 |
NDC Item 71288015605
| NDC 9 | 71288-156 |
|---|---|
| NDC 10 | 71288-156-05 |
| NDC Item | 71288015605 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-156 |
NDC Item 72205004501
| NDC 9 | 72205-045 |
|---|---|
| NDC 10 | 72205-045-01 |
| NDC Item | 72205004501 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-045-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-045 |
NDC Item 00143930901
| NDC 9 | 0143-9309 |
|---|---|
| NDC 10 | 0143-9309-01 |
| NDC Item | 00143930901 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 711646 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9309 |
NDC Item 00143956501
| NDC 9 | 0143-9565 |
|---|---|
| NDC 10 | 0143-9565-01 |
| NDC Item | 00143956501 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 598405 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9565 |
NDC Item 25021024602
| NDC 9 | 25021-246 |
|---|---|
| NDC 10 | 25021-246-02 |
| NDC Item | 25021024602 |
| Packaging | 1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIAL |
| ANDA | ANDA209150 |
| FDA SPL set id | 581120 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-246 |
NDC Item 43598065011
| NDC 9 | 43598-650 |
|---|---|
| NDC 10 | 43598-650-11 |
| NDC Item | 43598065011 |
| Packaging | 1 VIAL in 1 CARTON (43598-650-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA210337 |
| FDA SPL set id | 800887 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-05-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-650 |
NDC Item 54879001413
| NDC 9 | 54879-014 |
|---|---|
| NDC 10 | 54879-014-13 |
| NDC Item | 54879001413 |
| Packaging | 15 mg in 1 VIAL, SINGLE-USE (54879-014-13) |
| ANDA | ANDA208242 |
| FDA SPL set id | 670479 |
| Labeler | STI Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2016-10-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 54879-014 |
NDC Item 68083044601
| NDC 9 | 68083-446 |
|---|---|
| NDC 10 | 68083-446-01 |
| NDC Item | 68083044601 |
| Packaging | 1 VIAL in 1 CARTON (68083-446-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-03-08 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-446 |
NDC Item 69539012301
| NDC 9 | 69539-123 |
|---|---|
| NDC 10 | 69539-123-01 |
| NDC Item | 69539012301 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-123-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-123 |
NDC Item 71288015605
| NDC 9 | 71288-156 |
|---|---|
| NDC 10 | 71288-156-05 |
| NDC Item | 71288015605 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-156 |
NDC Item 72205004501
| NDC 9 | 72205-045 |
|---|---|
| NDC 10 | 72205-045-01 |
| NDC Item | 72205004501 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-045-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-045 |
NDC Item 00143930901
| NDC 9 | 0143-9309 |
|---|---|
| NDC 10 | 0143-9309-01 |
| NDC Item | 00143930901 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 711646 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9309 |
NDC Item 00143956501
| NDC 9 | 0143-9565 |
|---|---|
| NDC 10 | 0143-9565-01 |
| NDC Item | 00143956501 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 598405 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9565 |
NDC Item 25021024602
| NDC 9 | 25021-246 |
|---|---|
| NDC 10 | 25021-246-02 |
| NDC Item | 25021024602 |
| Packaging | 1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIAL |
| ANDA | ANDA209150 |
| FDA SPL set id | 581120 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-246 |
NDC Item 43598065011
| NDC 9 | 43598-650 |
|---|---|
| NDC 10 | 43598-650-11 |
| NDC Item | 43598065011 |
| Packaging | 1 VIAL in 1 CARTON (43598-650-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA210337 |
| FDA SPL set id | 800887 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-05-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-650 |
NDC Item 54879001413
| NDC 9 | 54879-014 |
|---|---|
| NDC 10 | 54879-014-13 |
| NDC Item | 54879001413 |
| Packaging | 15 mg in 1 VIAL, SINGLE-USE (54879-014-13) |
| ANDA | ANDA208242 |
| FDA SPL set id | 670479 |
| Labeler | STI Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2016-10-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 54879-014 |
NDC Item 68083044601
| NDC 9 | 68083-446 |
|---|---|
| NDC 10 | 68083-446-01 |
| NDC Item | 68083044601 |
| Packaging | 1 VIAL in 1 CARTON (68083-446-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-03-08 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-446 |
NDC Item 69539012301
| NDC 9 | 69539-123 |
|---|---|
| NDC 10 | 69539-123-01 |
| NDC Item | 69539012301 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-123-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-123 |
NDC Item 71288015605
| NDC 9 | 71288-156 |
|---|---|
| NDC 10 | 71288-156-05 |
| NDC Item | 71288015605 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-156 |
NDC Item 72205004501
| NDC 9 | 72205-045 |
|---|---|
| NDC 10 | 72205-045-01 |
| NDC Item | 72205004501 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-045-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-045 |
NDC Item 00143930901
| NDC 9 | 0143-9309 |
|---|---|
| NDC 10 | 0143-9309-01 |
| NDC Item | 00143930901 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 711646 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9309 |
NDC Item 00143956501
| NDC 9 | 0143-9565 |
|---|---|
| NDC 10 | 0143-9565-01 |
| NDC Item | 00143956501 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 598405 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9565 |
NDC Item 25021024602
| NDC 9 | 25021-246 |
|---|---|
| NDC 10 | 25021-246-02 |
| NDC Item | 25021024602 |
| Packaging | 1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIAL |
| ANDA | ANDA209150 |
| FDA SPL set id | 581120 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-246 |
NDC Item 43598065011
| NDC 9 | 43598-650 |
|---|---|
| NDC 10 | 43598-650-11 |
| NDC Item | 43598065011 |
| Packaging | 1 VIAL in 1 CARTON (43598-650-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA210337 |
| FDA SPL set id | 800887 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-05-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-650 |
NDC Item 54879001413
| NDC 9 | 54879-014 |
|---|---|
| NDC 10 | 54879-014-13 |
| NDC Item | 54879001413 |
| Packaging | 15 mg in 1 VIAL, SINGLE-USE (54879-014-13) |
| ANDA | ANDA208242 |
| FDA SPL set id | 670479 |
| Labeler | STI Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2016-10-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 54879-014 |
NDC Item 68083044601
| NDC 9 | 68083-446 |
|---|---|
| NDC 10 | 68083-446-01 |
| NDC Item | 68083044601 |
| Packaging | 1 VIAL in 1 CARTON (68083-446-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-03-08 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-446 |
NDC Item 69539012301
| NDC 9 | 69539-123 |
|---|---|
| NDC 10 | 69539-123-01 |
| NDC Item | 69539012301 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-123-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-123 |
NDC Item 71288015605
| NDC 9 | 71288-156 |
|---|---|
| NDC 10 | 71288-156-05 |
| NDC Item | 71288015605 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-156 |
NDC Item 72205004501
| NDC 9 | 72205-045 |
|---|---|
| NDC 10 | 72205-045-01 |
| NDC Item | 72205004501 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-045-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-045 |
NDC Item 00143930901
| NDC 9 | 0143-9309 |
|---|---|
| NDC 10 | 0143-9309-01 |
| NDC Item | 00143930901 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 711646 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9309 |
NDC Item 00143956501
| NDC 9 | 0143-9565 |
|---|---|
| NDC 10 | 0143-9565-01 |
| NDC Item | 00143956501 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 598405 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9565 |
NDC Item 25021024602
| NDC 9 | 25021-246 |
|---|---|
| NDC 10 | 25021-246-02 |
| NDC Item | 25021024602 |
| Packaging | 1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIAL |
| ANDA | ANDA209150 |
| FDA SPL set id | 581120 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-246 |
NDC Item 43598065011
| NDC 9 | 43598-650 |
|---|---|
| NDC 10 | 43598-650-11 |
| NDC Item | 43598065011 |
| Packaging | 1 VIAL in 1 CARTON (43598-650-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA210337 |
| FDA SPL set id | 800887 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-05-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-650 |
NDC Item 54879001413
| NDC 9 | 54879-014 |
|---|---|
| NDC 10 | 54879-014-13 |
| NDC Item | 54879001413 |
| Packaging | 15 mg in 1 VIAL, SINGLE-USE (54879-014-13) |
| ANDA | ANDA208242 |
| FDA SPL set id | 670479 |
| Labeler | STI Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2016-10-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 54879-014 |
NDC Item 68083044601
| NDC 9 | 68083-446 |
|---|---|
| NDC 10 | 68083-446-01 |
| NDC Item | 68083044601 |
| Packaging | 1 VIAL in 1 CARTON (68083-446-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-03-08 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-446 |
NDC Item 69539012301
| NDC 9 | 69539-123 |
|---|---|
| NDC 10 | 69539-123-01 |
| NDC Item | 69539012301 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-123-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-123 |
NDC Item 71288015605
| NDC 9 | 71288-156 |
|---|---|
| NDC 10 | 71288-156-05 |
| NDC Item | 71288015605 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-156 |
NDC Item 72205004501
| NDC 9 | 72205-045 |
|---|---|
| NDC 10 | 72205-045-01 |
| NDC Item | 72205004501 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-045-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-045 |
NDC Item 00143930901
| NDC 9 | 0143-9309 |
|---|---|
| NDC 10 | 0143-9309-01 |
| NDC Item | 00143930901 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 711646 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9309 |
NDC Item 00143956501
| NDC 9 | 0143-9565 |
|---|---|
| NDC 10 | 0143-9565-01 |
| NDC Item | 00143956501 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 598405 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9565 |
NDC Item 25021024602
| NDC 9 | 25021-246 |
|---|---|
| NDC 10 | 25021-246-02 |
| NDC Item | 25021024602 |
| Packaging | 1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIAL |
| ANDA | ANDA209150 |
| FDA SPL set id | 581120 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-246 |
NDC Item 43598065011
| NDC 9 | 43598-650 |
|---|---|
| NDC 10 | 43598-650-11 |
| NDC Item | 43598065011 |
| Packaging | 1 VIAL in 1 CARTON (43598-650-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA210337 |
| FDA SPL set id | 800887 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-05-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-650 |
NDC Item 54879001413
| NDC 9 | 54879-014 |
|---|---|
| NDC 10 | 54879-014-13 |
| NDC Item | 54879001413 |
| Packaging | 15 mg in 1 VIAL, SINGLE-USE (54879-014-13) |
| ANDA | ANDA208242 |
| FDA SPL set id | 670479 |
| Labeler | STI Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2016-10-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 54879-014 |
NDC Item 68083044601
| NDC 9 | 68083-446 |
|---|---|
| NDC 10 | 68083-446-01 |
| NDC Item | 68083044601 |
| Packaging | 1 VIAL in 1 CARTON (68083-446-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-03-08 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-446 |
NDC Item 69539012301
| NDC 9 | 69539-123 |
|---|---|
| NDC 10 | 69539-123-01 |
| NDC Item | 69539012301 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-123-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-123 |
NDC Item 71288015605
| NDC 9 | 71288-156 |
|---|---|
| NDC 10 | 71288-156-05 |
| NDC Item | 71288015605 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-156 |
NDC Item 72205004501
| NDC 9 | 72205-045 |
|---|---|
| NDC 10 | 72205-045-01 |
| NDC Item | 72205004501 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-045-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-045 |
NDC Item 00143930901
| NDC 9 | 0143-9309 |
|---|---|
| NDC 10 | 0143-9309-01 |
| NDC Item | 00143930901 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 711646 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9309 |
NDC Item 00143956501
| NDC 9 | 0143-9565 |
|---|---|
| NDC 10 | 0143-9565-01 |
| NDC Item | 00143956501 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 598405 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9565 |
NDC Item 25021024602
| NDC 9 | 25021-246 |
|---|---|
| NDC 10 | 25021-246-02 |
| NDC Item | 25021024602 |
| Packaging | 1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIAL |
| ANDA | ANDA209150 |
| FDA SPL set id | 581120 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-246 |
NDC Item 43598065011
| NDC 9 | 43598-650 |
|---|---|
| NDC 10 | 43598-650-11 |
| NDC Item | 43598065011 |
| Packaging | 1 VIAL in 1 CARTON (43598-650-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA210337 |
| FDA SPL set id | 800887 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-05-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-650 |
NDC Item 54879001413
| NDC 9 | 54879-014 |
|---|---|
| NDC 10 | 54879-014-13 |
| NDC Item | 54879001413 |
| Packaging | 15 mg in 1 VIAL, SINGLE-USE (54879-014-13) |
| ANDA | ANDA208242 |
| FDA SPL set id | 670479 |
| Labeler | STI Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2016-10-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 54879-014 |
NDC Item 68083044601
| NDC 9 | 68083-446 |
|---|---|
| NDC 10 | 68083-446-01 |
| NDC Item | 68083044601 |
| Packaging | 1 VIAL in 1 CARTON (68083-446-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-03-08 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-446 |
NDC Item 69539012301
| NDC 9 | 69539-123 |
|---|---|
| NDC 10 | 69539-123-01 |
| NDC Item | 69539012301 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-123-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-123 |
NDC Item 71288015605
| NDC 9 | 71288-156 |
|---|---|
| NDC 10 | 71288-156-05 |
| NDC Item | 71288015605 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-156 |
NDC Item 72205004501
| NDC 9 | 72205-045 |
|---|---|
| NDC 10 | 72205-045-01 |
| NDC Item | 72205004501 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-045-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-045 |
NDC Item 00143930901
| NDC 9 | 0143-9309 |
|---|---|
| NDC 10 | 0143-9309-01 |
| NDC Item | 00143930901 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 711646 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9309 |
NDC Item 00143956501
| NDC 9 | 0143-9565 |
|---|---|
| NDC 10 | 0143-9565-01 |
| NDC Item | 00143956501 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 598405 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9565 |
NDC Item 25021024602
| NDC 9 | 25021-246 |
|---|---|
| NDC 10 | 25021-246-02 |
| NDC Item | 25021024602 |
| Packaging | 1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIAL |
| ANDA | ANDA209150 |
| FDA SPL set id | 581120 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-246 |
NDC Item 43598065011
| NDC 9 | 43598-650 |
|---|---|
| NDC 10 | 43598-650-11 |
| NDC Item | 43598065011 |
| Packaging | 1 VIAL in 1 CARTON (43598-650-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA210337 |
| FDA SPL set id | 800887 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-05-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-650 |
NDC Item 54879001413
| NDC 9 | 54879-014 |
|---|---|
| NDC 10 | 54879-014-13 |
| NDC Item | 54879001413 |
| Packaging | 15 mg in 1 VIAL, SINGLE-USE (54879-014-13) |
| ANDA | ANDA208242 |
| FDA SPL set id | 670479 |
| Labeler | STI Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2016-10-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 54879-014 |
NDC Item 68083044601
| NDC 9 | 68083-446 |
|---|---|
| NDC 10 | 68083-446-01 |
| NDC Item | 68083044601 |
| Packaging | 1 VIAL in 1 CARTON (68083-446-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-03-08 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-446 |
NDC Item 69539012301
| NDC 9 | 69539-123 |
|---|---|
| NDC 10 | 69539-123-01 |
| NDC Item | 69539012301 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-123-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-123 |
NDC Item 71288015605
| NDC 9 | 71288-156 |
|---|---|
| NDC 10 | 71288-156-05 |
| NDC Item | 71288015605 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-156 |
NDC Item 72205004501
| NDC 9 | 72205-045 |
|---|---|
| NDC 10 | 72205-045-01 |
| NDC Item | 72205004501 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-045-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-045 |
NDC Item 00143930901
| NDC 9 | 0143-9309 |
|---|---|
| NDC 10 | 0143-9309-01 |
| NDC Item | 00143930901 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9309-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 711646 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9309 |
NDC Item 00143956501
| NDC 9 | 0143-9565 |
|---|---|
| NDC 10 | 0143-9565-01 |
| NDC Item | 00143956501 |
| Packaging | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) / 1.5 mL in 1 VIAL |
| ANDA | ANDA075547 |
| FDA SPL set id | 598405 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2001-06-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0143-9565 |
NDC Item 25021024602
| NDC 9 | 25021-246 |
|---|---|
| NDC 10 | 25021-246-02 |
| NDC Item | 25021024602 |
| Packaging | 1 VIAL in 1 CARTON (25021-246-02) / 1.5 mL in 1 VIAL |
| ANDA | ANDA209150 |
| FDA SPL set id | 581120 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-06-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-246 |
NDC Item 43598065011
| NDC 9 | 43598-650 |
|---|---|
| NDC 10 | 43598-650-11 |
| NDC Item | 43598065011 |
| Packaging | 1 VIAL in 1 CARTON (43598-650-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA210337 |
| FDA SPL set id | 800887 |
| Labeler | Dr.Reddy's Laboratories Inc., |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-05-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 43598-650 |
NDC Item 54879001413
| NDC 9 | 54879-014 |
|---|---|
| NDC 10 | 54879-014-13 |
| NDC Item | 54879001413 |
| Packaging | 15 mg in 1 VIAL, SINGLE-USE (54879-014-13) |
| ANDA | ANDA208242 |
| FDA SPL set id | 670479 |
| Labeler | STI Pharma LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2016-10-07 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 54879-014 |
NDC Item 68083044601
| NDC 9 | 68083-446 |
|---|---|
| NDC 10 | 68083-446-01 |
| NDC Item | 68083044601 |
| Packaging | 1 VIAL in 1 CARTON (68083-446-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA214222 |
| FDA SPL set id | 609541 |
| Labeler | Gland Pharma Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2021-03-08 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 68083-446 |
NDC Item 69539012301
| NDC 9 | 69539-123 |
|---|---|
| NDC 10 | 69539-123-01 |
| NDC Item | 69539012301 |
| Packaging | 1 VIAL, GLASS in 1 BOX (69539-123-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 456772 |
| Labeler | MSN LABORATORIES PRIVATE LIMITED |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-03-04 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 69539-123 |
NDC Item 71288015605
| NDC 9 | 71288-156 |
|---|---|
| NDC 10 | 71288-156-05 |
| NDC Item | 71288015605 |
| Packaging | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-156-05) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| ANDA | ANDA216037 |
| FDA SPL set id | 758393 |
| Labeler | Meitheal Pharmaceuticals Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-12-26 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-156 |
NDC Item 72205004501
| NDC 9 | 72205-045 |
|---|---|
| NDC 10 | 72205-045-01 |
| NDC Item | 72205004501 |
| Packaging | 1 VIAL, GLASS in 1 BOX (72205-045-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| ANDA | ANDA213049 |
| COLORTEXT | WHITE |
| Color | C48325 __ |
| FDA SPL set id | 463379 |
| Labeler | Novadoz Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2020-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72205-045 |