Application 076604
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE; IBUPROFEN | TABLET;ORAL | 7.5MG;200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33261-378 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE AND IBUPROFEN | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 49999-588 | Hydrocodone Bitartrate and Ibuprofen | Hydrocodone Bitartrate and Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 62037-524 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE AND IBUPROFEN | Actavis Pharma, Inc. | ANDA | Current |
| 67296-1282 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE AND IBUPROFEN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1282 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE AND IBUPROFEN | RedPharm Drug, Inc. | ANDA | Current |
| 71335-0094 | HYDROCODONE BITARTRATE AND IBUPROFEN | HYDROCODONE BITARTRATE AND IBUPROFEN | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76306 | ORIG | 2023-11-03 |