Application 078316
- Type
- ANDA
- Sponsor
- BARR LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE HYDROCHLORIDE AND IBUPROFEN | IBUPROFEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 400MG;5MG | No | Yes |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76311 | ORIG | 2023-11-03 |