Data updated: Mar 10, 2026
BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE
Approved 1999-11-29
55
Indications
--
Phase 3 Trials
26
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1999-11-29
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET
Companies
Sun Pharma MICRO LABS ACCORD HLTHCARE WATSON LABS INC RISING JUBILANT GENERICS INVAGEN PHARMS GRAVITI PHARMS YICHANG HUMANWELL ANNORA PHARMA IMPAX LABS WOCKHARDT LTD IPCA LABS LTD GRANULES EPIC PHARMA LLC ZYDUS PHARMS ANBISON LAB SINOTHERAPEUTICS INC ZHEJIANG JUTAI PHARM Novartis PH HEALTH Teva HERITAGE PHARMA TWI PHARMS Aurobindo Pharma Lupin INVATECH CHARTWELL RX SCIEGEN PHARMS CADILA PHARMS LTD Apotex PRINSTON INC ALEMBIC TORRENT SENORES PHARMS
Active Ingredient: BUPROPION HYDROCHLORIDE
Website: ↗
BUPROPION HYDROCHLORIDE Approval History
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What BUPROPION HYDROCHLORIDE Treats
55 FDA approvalsOriginally approved for its first indication in 1999 . Covers 55 distinct patient populations.
- Other (55)
Other
(55 approvals)- • Approved indication (Nov 1999)
- • Approved indication (Feb 2000)Letter
- • Approved indication (Apr 2000)Letter
- • Approved indication (Oct 2000)Letter
- • Approved indication (Nov 2003)Letter
- • Approved indication (Jan 2004)Letter
- • Approved indication (May 2004)
- • Approved indication (Dec 2004)
- • Approved indication (Jul 2005)
- • Approved indication (Jan 2006)
- • Approved indication (Dec 2006)Label Letter
- • Approved indication (Dec 2006)Letter
- • Approved indication (Jun 2007)
- • Approved indication (Mar 2008)
- • Approved indication (Aug 2008)
- • Approved indication (Mar 2009)
- • Approved indication (Apr 2010)
- • Approved indication (Apr 2010)
- • Approved indication (May 2010)
- • Approved indication (Jul 2010)
- • Approved indication (Jun 2011)
- • Approved indication (Aug 2012)
- • Approved indication (Nov 2012)
- • Approved indication (Oct 2013)
- • Approved indication (Jan 2014)
- • Approved indication (Oct 2014)
- • Approved indication (Dec 2014)
- • Approved indication (May 2015)
- • Approved indication (Feb 2016)Letter
- • Approved indication (Mar 2016)Letter
- • Approved indication (Aug 2016)Letter
- • Approved indication (Aug 2016)
- • Approved indication (Aug 2016)
- • Approved indication (Apr 2017)
- • Approved indication (Apr 2017)
- • Approved indication (Jun 2017)
- • Approved indication (Aug 2017)
- • Approved indication (Sep 2017)
- • Approved indication (Nov 2017)
- • Approved indication (Jun 2018)
- • Approved indication (Jun 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Jan 2019)
- • Approved indication (Sep 2019)
- • Approved indication (Jan 2020)
- • Approved indication (Apr 2020)
- • Approved indication (Nov 2020)
- • Approved indication (Dec 2020)
- • Approved indication (Feb 2022)
- • Approved indication (Jan 2023)
- • Approved indication (May 2023)
- • Approved indication (Oct 2024)
- • Approved indication (May 2025) New
- • Approved indication (Oct 2025) New
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
BUPROPION HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.