FdaApplication
ANDA 216050
Identifiers
- fda_app_no: ANDA216050
Properties
| Property | Value |
|---|---|
| applicant_name | SOMERSET THERAPEUTICS LLC |
| application_type | ANDA |
| approval_date | 2024-09-19 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 10MG/ML (10MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 20MG/ML (20MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
2 products