# NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE
> **ANDA208043** · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL INC · Approved 2022-11-29
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208043)
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