# NALBUPHINE HYDROCHLORIDE
> **ANDA216050** · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET THERAPS LLC · Approved 2024-09-19
## Drug
- **FDA Application Number:** ANDA216050
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** NALBUPHINE HYDROCHLORIDE
- **Generic name:** NALBUPHINE HYDROCHLORIDE
- **Active ingredients:** NALBUPHINE HYDROCHLORIDE
- **Dosage form:** SOLUTION
- **Route:** INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- **Marketing status:** Prescription
- **Sponsor:** SOMERSET THERAPS LLC
- **Manufacturer:** Somerset Therapeutics, LLC
- **First approval:** 2024-09-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216050)
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