← FDA Drug Approvals (Drugs@FDA)
NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL INC · Approved 2022-11-29
Drug application
- FDA Application #
ANDA208043- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE
- Generic name
- Naltrexone Hydrochloride
- Active ingredients
- NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- ACTAVIS LABS FL INC
- First approval
- 2022-11-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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