Application 216049
- Type
- ANDA
- Sponsor
- SOMERSET THERAPS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 100MG/10ML (10MG/ML) | No | No |
| 002 | NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 200MG/10ML (20MG/ML) | No | No |