Composition
- Active ingredients
- BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE; NALOXONE HYDROCHLORIDE EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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EQ 2MG BASE; NALOXONE HYDROCHLORIDE EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletThis page
- BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE; NALOXONE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA020733-002 · Discontinued
- BUPRENORPHINE HYDROCHLORIDE EQ 12MG BASE; NALOXONE HYDROCHLORIDE EQ 3MG BASE · FilmNDA022410-004 · Prescription
- BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE; NALOXONE HYDROCHLORIDE EQ 2MG BASE · FilmNDA022410-002 · Prescription
- BUPRENORPHINE HYDROCHLORIDE EQ 4MG BASE; NALOXONE HYDROCHLORIDE EQ 1MG BASE · FilmNDA022410-003 · Prescription
- BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE; NALOXONE HYDROCHLORIDE EQ 0.5MG BASE · FilmNDA022410-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA020733.
At a glance
- Brand name
- Suboxone
- Active substance
- buprenorphine hydrochloride
- Route
- Under the tongue
- Dosage form
- Tablet
- Applicant
- Indivior
- Status
- Discontinued
- FDA approval
- 8 Oct 2002
- Application
- NDA020733-001