Drug application
NALBUPHINE HYDROCHLORIDE (NALBUPHINE HYDROCHLORIDE)
Drugs@FDA ANDA 216049 · SOMERSET THERAPS LLC
Key facts
| Drug name | NALBUPHINE HYDROCHLORIDE |
|---|---|
| Active ingredients | NALBUPHINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 216049 |
| Company | SOMERSET THERAPS LLC |
| Dosage forms | SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| Strength | 100MG/10ML (10MG/ML) |
| Marketing status | Prescription |
| TE codes | AP |
| Reference listed drug | No |
| Latest submission status date | Sep 19, 2024 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.