# BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
> **ANDA204383** · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS UT INC · Approved 2017-10-24
## Drug
- **FDA Application Number:** ANDA204383
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- **Generic name:** Buprenorphine Hydrochloride
- **Active ingredients:** BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- **Dosage form:** FILM
- **Route:** BUCCAL, SUBLINGUAL
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** ACTAVIS LABS UT INC
- **First approval:** 2017-10-24
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204383)
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