Data updated: Mar 10, 2026
BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE
Approved 1996-06-03
15
Indications
--
Phase 3 Trials
29
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1996-06-03
- Routes
- SUBLINGUAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
Companies
Teva RUBICON RESEARCH SPECGX LLC ASCENT PHARMS INC PH HEALTH Hikma ETHYPHARM Sun Pharma SOMERSET THERAPS LLC AM REGENT PHARMOBEDIENT RHODES PHARMS Pfizer
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE
Website: ↗
BUPRENORPHINE HYDROCHLORIDE Approval History
Loading approval history...
What BUPRENORPHINE HYDROCHLORIDE Treats
15 FDA approvalsOriginally approved for its first indication in 1996 . Covers 15 distinct patient populations.
- Other (15)
Other
(15 approvals)- • Approved indication (Jun 1996)
- • Approved indication (Mar 2005)
- • Approved indication (Mar 2007)
- • Approved indication (Oct 2009)Letter
- • Approved indication (May 2010)
- • Approved indication (Sep 2010)
- • Approved indication (Feb 2015)Letter
- • Approved indication (Mar 2015)
- • Approved indication (Jun 2015)
- • Approved indication (Jul 2015)Letter
- • Approved indication (Jan 2016)Letter
- • Approved indication (Mar 2017)
- • Approved indication (Jan 2025)
- • Approved indication (Dec 2025) New
- • Approved indication (Dec 2025) New
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BUPRENORPHINE HYDROCHLORIDE FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.