# BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
> **ANDA091422** · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS ELIZABETH · Approved 2013-02-22
## Drug
- **FDA Application Number:** ANDA091422
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- **Generic name:** BUPRENORPHINE AND NALOXONE
- **Active ingredients:** BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** SUBLINGUAL
- **Marketing status:** Prescription
- **Sponsor:** ACTAVIS ELIZABETH
- **Manufacturer:** Actavis Pharma, Inc.
- **First approval:** 2013-02-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=091422)
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