Composition
- Active ingredients
- BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletThis page
- BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA020732-003 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA020732.
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
- Subutex
- Active substance
- buprenorphine hydrochloride
- Route
- Under the tongue
- Dosage form
- Tablet
- Applicant
- Indivior
- Status
- Discontinued
- FDA approval
- 8 Oct 2002
- Application
- NDA020732-002