Composition
- Active ingredients
- NALTREXONE HYDROCHLORIDE 8MG/90MG; BUPROPION HYDROCHLORIDE
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA208043.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Naltrexone Hydrochloride; Bupropion Hydrochloride
- Active substance
- naltrexone hydrochloride
- Route
- Oral
- Dosage form
- Tablet, extended release
- Applicant
- Actavis Labs FL Inc
- Status
- Tentative approval
- FDA approval
- 29 Nov 2022
- Application
- ANDA208043-001