← FDA Drug Approvals (Drugs@FDA)
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS UT INC · Approved 2017-10-24
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown