# BUPRENORPHINE HYDROCHLORIDE
> **ANDA219401** · Abbreviated New Drug Application (Generic) · Sponsor: ASCENT PHARMS INC · Approved 2025-12-18
## Drug
- **FDA Application Number:** ANDA219401
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BUPRENORPHINE HYDROCHLORIDE
- **Generic name:** BUPRENORPHINE HCL
- **Active ingredients:** BUPRENORPHINE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** SUBLINGUAL
- **Marketing status:** Prescription
- **Sponsor:** ASCENT PHARMS INC
- **Manufacturer:** Camber Pharmaceuticals, Inc.
- **First approval:** 2025-12-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219401)
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