NDC properties for "SMX 80 MG/ML / TMP 16 MG/ML Injectable Solution" (RxCUI 313137)
About this data
The tables show NDC propoerties for SMX 80 MG/ML / TMP 16 MG/ML Injectable Solution with the RxCUI 313137
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 SMX 80 MG/ML / TMP 16 MG/ML Injectable Solution (RxCUI 313137)
| ANDA | ANDA073303 |
|---|---|
| ANDA | ANDA206607 |
| ANDA | ANDA212231 |
| MMSL_CODE | CD3230 |
| MMSL_CODE | MTH_RXN_BD3230 |
| RxCUI | 313137 |
| SNOMEDCT | 1145274008 |
| SNOMEDCT | 782130009 |
| SPL_SET_ID | 24ff620f-d84d-43b8-a82b-97fc1a1a2916 |
| SPL_SET_ID | 640f5b0c-748d-4a68-a1de-59cc3e00ed49 |
| SPL_SET_ID | 793c75eb-dd65-4b6d-ac46-6e57ce1334f7 |
| SPL_SET_ID | b89b5502-ce87-45a6-a43c-9891da3cfca4 |
| SPL_SET_ID | bf7a0845-de4f-46be-841a-0faf47f8b530 |
| SPL_SET_ID | ebb570bb-6e5e-489e-875c-9e7b3a6d716a |
| VUID | 4001956 |
| Prescribable Synonym | sulfamethoxazole 80 MG / trimethoprim 16 MG in 1 ML Injectable Solution |
| RXNAV_STR | sulfamethoxazole 80 MG/ML / trimethoprim 16 MG/ML Injectable Solution |
| RxNorm Name | sulfamethoxazole 80 MG/ML / trimethoprim 16 MG/ML Injectable Solution |
| RxNorm Synonym | SMX 80 MG/ML / TMP 16 MG/ML Injectable Solution |
| RxNorm Synonym | sulfamethoxazole 80 MG / trimethoprim 16 MG per 1 ML Injectable Solution |
| Related queries | Interactions (for RxCUI 313137) |
NDC Properties
NDC Item 00703951401
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-01 |
| NDC Item | 00703951401 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951403
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-03 |
| NDC Item | 00703951403 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951481
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-81 |
| NDC Item | 00703951481 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951483
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-83 |
| NDC Item | 00703951483 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951491
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-91 |
| NDC Item | 00703951491 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951493
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-93 |
| NDC Item | 00703951493 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703952601
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-01 |
| NDC Item | 00703952601 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 00703952681
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-81 |
| NDC Item | 00703952681 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 67457077930
| NDC 9 | 67457-779 |
|---|---|
| NDC 10 | 67457-779-30 |
| NDC Item | 67457077930 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-779-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-06-30 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-779 |
NDC Item 67457092230
| NDC 9 | 67457-922 |
|---|---|
| NDC 10 | 67457-922-30 |
| NDC Item | 67457092230 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-922-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-922 |
NDC Item 70069036201
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-01 |
| NDC Item | 70069036201 |
| Packaging | 10 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036210
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-10 |
| NDC Item | 70069036210 |
| Packaging | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036301
| NDC 9 | 70069-363 |
|---|---|
| NDC 10 | 70069-363-01 |
| NDC Item | 70069036301 |
| Packaging | 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-363 |
NDC Item 00703951401
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-01 |
| NDC Item | 00703951401 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951403
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-03 |
| NDC Item | 00703951403 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951481
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-81 |
| NDC Item | 00703951481 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951483
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-83 |
| NDC Item | 00703951483 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951491
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-91 |
| NDC Item | 00703951491 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951493
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-93 |
| NDC Item | 00703951493 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703952601
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-01 |
| NDC Item | 00703952601 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 00703952681
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-81 |
| NDC Item | 00703952681 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 67457077930
| NDC 9 | 67457-779 |
|---|---|
| NDC 10 | 67457-779-30 |
| NDC Item | 67457077930 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-779-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-06-30 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-779 |
NDC Item 67457092230
| NDC 9 | 67457-922 |
|---|---|
| NDC 10 | 67457-922-30 |
| NDC Item | 67457092230 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-922-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-922 |
NDC Item 70069036201
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-01 |
| NDC Item | 70069036201 |
| Packaging | 10 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036210
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-10 |
| NDC Item | 70069036210 |
| Packaging | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036301
| NDC 9 | 70069-363 |
|---|---|
| NDC 10 | 70069-363-01 |
| NDC Item | 70069036301 |
| Packaging | 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-363 |
NDC Item 00703951401
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-01 |
| NDC Item | 00703951401 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951403
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-03 |
| NDC Item | 00703951403 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951481
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-81 |
| NDC Item | 00703951481 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951483
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-83 |
| NDC Item | 00703951483 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951491
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-91 |
| NDC Item | 00703951491 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951493
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-93 |
| NDC Item | 00703951493 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703952601
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-01 |
| NDC Item | 00703952601 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 00703952681
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-81 |
| NDC Item | 00703952681 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 67457077930
| NDC 9 | 67457-779 |
|---|---|
| NDC 10 | 67457-779-30 |
| NDC Item | 67457077930 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-779-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-06-30 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-779 |
NDC Item 67457092230
| NDC 9 | 67457-922 |
|---|---|
| NDC 10 | 67457-922-30 |
| NDC Item | 67457092230 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-922-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-922 |
NDC Item 70069036201
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-01 |
| NDC Item | 70069036201 |
| Packaging | 10 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036210
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-10 |
| NDC Item | 70069036210 |
| Packaging | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036301
| NDC 9 | 70069-363 |
|---|---|
| NDC 10 | 70069-363-01 |
| NDC Item | 70069036301 |
| Packaging | 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-363 |
NDC Item 00703951401
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-01 |
| NDC Item | 00703951401 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951403
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-03 |
| NDC Item | 00703951403 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951481
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-81 |
| NDC Item | 00703951481 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951483
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-83 |
| NDC Item | 00703951483 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951491
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-91 |
| NDC Item | 00703951491 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951493
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-93 |
| NDC Item | 00703951493 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703952601
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-01 |
| NDC Item | 00703952601 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 00703952681
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-81 |
| NDC Item | 00703952681 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 67457077930
| NDC 9 | 67457-779 |
|---|---|
| NDC 10 | 67457-779-30 |
| NDC Item | 67457077930 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-779-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-06-30 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-779 |
NDC Item 67457092230
| NDC 9 | 67457-922 |
|---|---|
| NDC 10 | 67457-922-30 |
| NDC Item | 67457092230 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-922-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-922 |
NDC Item 70069036201
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-01 |
| NDC Item | 70069036201 |
| Packaging | 10 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036210
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-10 |
| NDC Item | 70069036210 |
| Packaging | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036301
| NDC 9 | 70069-363 |
|---|---|
| NDC 10 | 70069-363-01 |
| NDC Item | 70069036301 |
| Packaging | 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-363 |
NDC Item 00703951401
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-01 |
| NDC Item | 00703951401 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951403
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-03 |
| NDC Item | 00703951403 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951481
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-81 |
| NDC Item | 00703951481 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951483
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-83 |
| NDC Item | 00703951483 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951491
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-91 |
| NDC Item | 00703951491 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951493
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-93 |
| NDC Item | 00703951493 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703952601
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-01 |
| NDC Item | 00703952601 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 00703952681
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-81 |
| NDC Item | 00703952681 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 67457077930
| NDC 9 | 67457-779 |
|---|---|
| NDC 10 | 67457-779-30 |
| NDC Item | 67457077930 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-779-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-06-30 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-779 |
NDC Item 67457092230
| NDC 9 | 67457-922 |
|---|---|
| NDC 10 | 67457-922-30 |
| NDC Item | 67457092230 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-922-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-922 |
NDC Item 70069036201
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-01 |
| NDC Item | 70069036201 |
| Packaging | 10 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036210
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-10 |
| NDC Item | 70069036210 |
| Packaging | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036301
| NDC 9 | 70069-363 |
|---|---|
| NDC 10 | 70069-363-01 |
| NDC Item | 70069036301 |
| Packaging | 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-363 |
NDC Item 00703951401
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-01 |
| NDC Item | 00703951401 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951403
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-03 |
| NDC Item | 00703951403 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951481
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-81 |
| NDC Item | 00703951481 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951483
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-83 |
| NDC Item | 00703951483 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951491
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-91 |
| NDC Item | 00703951491 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951493
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-93 |
| NDC Item | 00703951493 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703952601
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-01 |
| NDC Item | 00703952601 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 00703952681
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-81 |
| NDC Item | 00703952681 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 67457077930
| NDC 9 | 67457-779 |
|---|---|
| NDC 10 | 67457-779-30 |
| NDC Item | 67457077930 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-779-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-06-30 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-779 |
NDC Item 67457092230
| NDC 9 | 67457-922 |
|---|---|
| NDC 10 | 67457-922-30 |
| NDC Item | 67457092230 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-922-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-922 |
NDC Item 70069036201
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-01 |
| NDC Item | 70069036201 |
| Packaging | 10 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036210
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-10 |
| NDC Item | 70069036210 |
| Packaging | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036301
| NDC 9 | 70069-363 |
|---|---|
| NDC 10 | 70069-363-01 |
| NDC Item | 70069036301 |
| Packaging | 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-363 |
NDC Item 00703951401
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-01 |
| NDC Item | 00703951401 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951403
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-03 |
| NDC Item | 00703951403 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951481
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-81 |
| NDC Item | 00703951481 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951483
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-83 |
| NDC Item | 00703951483 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951491
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-91 |
| NDC Item | 00703951491 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951493
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-93 |
| NDC Item | 00703951493 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703952601
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-01 |
| NDC Item | 00703952601 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 00703952681
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-81 |
| NDC Item | 00703952681 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 67457077930
| NDC 9 | 67457-779 |
|---|---|
| NDC 10 | 67457-779-30 |
| NDC Item | 67457077930 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-779-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-06-30 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-779 |
NDC Item 67457092230
| NDC 9 | 67457-922 |
|---|---|
| NDC 10 | 67457-922-30 |
| NDC Item | 67457092230 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-922-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-922 |
NDC Item 70069036201
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-01 |
| NDC Item | 70069036201 |
| Packaging | 10 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036210
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-10 |
| NDC Item | 70069036210 |
| Packaging | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036301
| NDC 9 | 70069-363 |
|---|---|
| NDC 10 | 70069-363-01 |
| NDC Item | 70069036301 |
| Packaging | 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-363 |
NDC Item 00703951401
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-01 |
| NDC Item | 00703951401 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951403
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-03 |
| NDC Item | 00703951403 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951481
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-81 |
| NDC Item | 00703951481 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951483
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-83 |
| NDC Item | 00703951483 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951491
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-91 |
| NDC Item | 00703951491 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951493
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-93 |
| NDC Item | 00703951493 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703952601
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-01 |
| NDC Item | 00703952601 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 00703952681
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-81 |
| NDC Item | 00703952681 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 67457077930
| NDC 9 | 67457-779 |
|---|---|
| NDC 10 | 67457-779-30 |
| NDC Item | 67457077930 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-779-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-06-30 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-779 |
NDC Item 67457092230
| NDC 9 | 67457-922 |
|---|---|
| NDC 10 | 67457-922-30 |
| NDC Item | 67457092230 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-922-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-922 |
NDC Item 70069036201
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-01 |
| NDC Item | 70069036201 |
| Packaging | 10 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036210
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-10 |
| NDC Item | 70069036210 |
| Packaging | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036301
| NDC 9 | 70069-363 |
|---|---|
| NDC 10 | 70069-363-01 |
| NDC Item | 70069036301 |
| Packaging | 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-363 |
NDC Item 00703951401
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-01 |
| NDC Item | 00703951401 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951403
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-03 |
| NDC Item | 00703951403 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951481
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-81 |
| NDC Item | 00703951481 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951483
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-83 |
| NDC Item | 00703951483 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951491
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-91 |
| NDC Item | 00703951491 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951493
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-93 |
| NDC Item | 00703951493 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703952601
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-01 |
| NDC Item | 00703952601 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 00703952681
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-81 |
| NDC Item | 00703952681 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 67457077930
| NDC 9 | 67457-779 |
|---|---|
| NDC 10 | 67457-779-30 |
| NDC Item | 67457077930 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-779-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-06-30 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-779 |
NDC Item 67457092230
| NDC 9 | 67457-922 |
|---|---|
| NDC 10 | 67457-922-30 |
| NDC Item | 67457092230 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-922-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-922 |
NDC Item 70069036201
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-01 |
| NDC Item | 70069036201 |
| Packaging | 10 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036210
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-10 |
| NDC Item | 70069036210 |
| Packaging | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036301
| NDC 9 | 70069-363 |
|---|---|
| NDC 10 | 70069-363-01 |
| NDC Item | 70069036301 |
| Packaging | 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-363 |
NDC Item 00703951401
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-01 |
| NDC Item | 00703951401 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951403
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-03 |
| NDC Item | 00703951403 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951481
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-81 |
| NDC Item | 00703951481 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951483
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-83 |
| NDC Item | 00703951483 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951491
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-91 |
| NDC Item | 00703951491 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951493
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-93 |
| NDC Item | 00703951493 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703952601
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-01 |
| NDC Item | 00703952601 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 00703952681
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-81 |
| NDC Item | 00703952681 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 67457077930
| NDC 9 | 67457-779 |
|---|---|
| NDC 10 | 67457-779-30 |
| NDC Item | 67457077930 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-779-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-06-30 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-779 |
NDC Item 67457092230
| NDC 9 | 67457-922 |
|---|---|
| NDC 10 | 67457-922-30 |
| NDC Item | 67457092230 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-922-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-922 |
NDC Item 70069036201
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-01 |
| NDC Item | 70069036201 |
| Packaging | 10 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036210
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-10 |
| NDC Item | 70069036210 |
| Packaging | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036301
| NDC 9 | 70069-363 |
|---|---|
| NDC 10 | 70069-363-01 |
| NDC Item | 70069036301 |
| Packaging | 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-363 |
NDC Item 00703951401
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-01 |
| NDC Item | 00703951401 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951403
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-03 |
| NDC Item | 00703951403 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951481
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-81 |
| NDC Item | 00703951481 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951483
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-83 |
| NDC Item | 00703951483 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951491
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-91 |
| NDC Item | 00703951491 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951493
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-93 |
| NDC Item | 00703951493 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703952601
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-01 |
| NDC Item | 00703952601 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 00703952681
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-81 |
| NDC Item | 00703952681 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 67457077930
| NDC 9 | 67457-779 |
|---|---|
| NDC 10 | 67457-779-30 |
| NDC Item | 67457077930 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-779-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-06-30 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-779 |
NDC Item 67457092230
| NDC 9 | 67457-922 |
|---|---|
| NDC 10 | 67457-922-30 |
| NDC Item | 67457092230 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-922-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-922 |
NDC Item 70069036201
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-01 |
| NDC Item | 70069036201 |
| Packaging | 10 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036210
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-10 |
| NDC Item | 70069036210 |
| Packaging | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036301
| NDC 9 | 70069-363 |
|---|---|
| NDC 10 | 70069-363-01 |
| NDC Item | 70069036301 |
| Packaging | 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-363 |
NDC Item 00703951401
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-01 |
| NDC Item | 00703951401 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951403
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-03 |
| NDC Item | 00703951403 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951481
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-81 |
| NDC Item | 00703951481 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951483
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-83 |
| NDC Item | 00703951483 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951491
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-91 |
| NDC Item | 00703951491 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951493
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-93 |
| NDC Item | 00703951493 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703952601
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-01 |
| NDC Item | 00703952601 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 00703952681
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-81 |
| NDC Item | 00703952681 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 67457077930
| NDC 9 | 67457-779 |
|---|---|
| NDC 10 | 67457-779-30 |
| NDC Item | 67457077930 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-779-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-06-30 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-779 |
NDC Item 67457092230
| NDC 9 | 67457-922 |
|---|---|
| NDC 10 | 67457-922-30 |
| NDC Item | 67457092230 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-922-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-922 |
NDC Item 70069036201
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-01 |
| NDC Item | 70069036201 |
| Packaging | 10 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036210
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-10 |
| NDC Item | 70069036210 |
| Packaging | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036301
| NDC 9 | 70069-363 |
|---|---|
| NDC 10 | 70069-363-01 |
| NDC Item | 70069036301 |
| Packaging | 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-363 |
NDC Item 00703951401
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-01 |
| NDC Item | 00703951401 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951403
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-03 |
| NDC Item | 00703951403 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951481
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-81 |
| NDC Item | 00703951481 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951483
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-83 |
| NDC Item | 00703951483 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951491
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-91 |
| NDC Item | 00703951491 |
| Packaging | 10 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703951493
| NDC 9 | 0703-9514 |
|---|---|
| NDC 10 | 0703-9514-93 |
| NDC Item | 00703951493 |
| Packaging | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 716880 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-07-11 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9514 |
NDC Item 00703952601
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-01 |
| NDC Item | 00703952601 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 00703952681
| NDC 9 | 0703-9526 |
|---|---|
| NDC 10 | 0703-9526-81 |
| NDC Item | 00703952681 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-81) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA073303 |
| FDA SPL set id | 716741 |
| FDA SPL set id | 813866 |
| Labeler | Teva Parenteral Medicines, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-15 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0703-9526 |
NDC Item 67457077930
| NDC 9 | 67457-779 |
|---|---|
| NDC 10 | 67457-779-30 |
| NDC Item | 67457077930 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-779-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 849345 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-06-30 |
| Marketing effective time low | 2017-12-31 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-779 |
NDC Item 67457092230
| NDC 9 | 67457-922 |
|---|---|
| NDC 10 | 67457-922-30 |
| NDC Item | 67457092230 |
| Packaging | 1 VIAL, MULTI-DOSE in 1 CARTON (67457-922-30) / 30 mL in 1 VIAL, MULTI-DOSE |
| ANDA | ANDA206607 |
| FDA SPL set id | 825030 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-03-31 |
| Marketing effective time low | 2020-10-12 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-922 |
NDC Item 70069036201
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-01 |
| NDC Item | 70069036201 |
| Packaging | 10 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036210
| NDC 9 | 70069-362 |
|---|---|
| NDC 10 | 70069-362-10 |
| NDC Item | 70069036210 |
| Packaging | 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-362 |
NDC Item 70069036301
| NDC 9 | 70069-363 |
|---|---|
| NDC 10 | 70069-363-01 |
| NDC Item | 70069036301 |
| Packaging | 1 VIAL in 1 CARTON (70069-363-01) / 30 mL in 1 VIAL |
| ANDA | ANDA212231 |
| COLORTEXT | YELLOW(Clear, colorless to pale yellow solution) |
| Color | C48330 __ |
| FDA SPL set id | 723076 |
| Labeler | Somerset Therapeutics, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-08-29 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 70069-363 |