Data updated: Mar 10, 2026
GABAPENTIN
GABAPENTIN
Approved 2003-09-12
63
Indications
--
Phase 3 Trials
22
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2003-09-12
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET, SOLUTION
Companies
CHARTWELL RX STRIDES PHARMA Teva ACELLA PHARMS LLC GLENMARK PHARMS LTD INVAGEN PHARMS IPCA LABS LTD ANNORA PHARMA SENORES PHARMS TARO RUBICON RESEARCH ALKEM ALKEM LABS LTD ZHEJIANG YONGTAI ASCENT PHARMS INC HUMANWELL AMNEAL PHARMS NY MISSION PHARMACAL ZYDUS PHARMS Lupin GRANULES RISING Novartis IVAX SUB TEVA PHARMS Sun Pharma MARKSANS PHARMA SCIEGEN PHARMS Apotex Hikma PHARMOBEDIENT AJENAT PHARMS Aurobindo Pharma AMNEAL PHARMS LAURUS ZYDUS PHARMS USA INC ABON PHARMS LLC PAI HOLDINGS PHARM CSPC OUYI WATSON LABS RANBAXY
Active Ingredient: GABAPENTIN
Website: ↗
GABAPENTIN Approval History
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What GABAPENTIN Treats
63 FDA approvalsOriginally approved for its first indication in 2003 . Covers 63 distinct patient populations.
- Other (63)
Other
(63 approvals)- • Approved indication (Sep 2003)
- • Approved indication (Apr 2004)Letter
- • Approved indication (Oct 2004)Letter
- • Approved indication (Oct 2004)
- • Approved indication (Dec 2004)
- • Approved indication (Mar 2005)
- • Approved indication (Apr 2005)
- • Approved indication (Jun 2005)
- • Approved indication (Sep 2005)
- • Approved indication (Oct 2005)
- • Approved indication (Jan 2006)
- • Approved indication (Jan 2006)
- • Approved indication (Jul 2006)
- • Approved indication (Aug 2006)
- • Approved indication (Aug 2006)
- • Approved indication (Sep 2006)
- • Approved indication (Oct 2006)
- • Approved indication (May 2007)
- • Approved indication (Jul 2007)
- • Approved indication (Sep 2007)
- • Approved indication (Jan 2008)
- • Approved indication (Dec 2009)
- • Approved indication (Jun 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Feb 2011)
- • Approved indication (Feb 2011)
- • Approved indication (Feb 2011)Letter
- • Approved indication (Jul 2011)
- • Approved indication (Oct 2011)
- • Approved indication (Mar 2012)
- • Approved indication (May 2012)
- • Approved indication (Oct 2012)
- • Approved indication (Jul 2013)
- • Approved indication (Jul 2013)
- • Approved indication (Aug 2013)
- • Approved indication (Dec 2015)
- • Approved indication (Feb 2016)Letter
- • Approved indication (Feb 2016)Letter
- • Approved indication (Mar 2016)
- • Approved indication (Mar 2017)
- • Approved indication (Mar 2017)
- • Approved indication (Oct 2017)
- • Approved indication (May 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Dec 2019)
- • Approved indication (Aug 2020)
- • Approved indication (May 2021)
- • Approved indication (Oct 2021)
- • Approved indication (Jan 2023)
- • Approved indication (Mar 2023)
- • Approved indication (May 2023)
- • Approved indication (Jul 2023)
- • Approved indication (Nov 2023)
- • Approved indication (Jan 2024)
- • Approved indication (Jan 2024)Letter
- • Approved indication (Feb 2024)
- • Approved indication (Mar 2024)
- • Approved indication (Apr 2024)
- • Approved indication (May 2024)
- • Approved indication (Sep 2024)
- • Approved indication (Aug 2025) New
- • Approved indication (Sep 2025) New
🔬
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.
GABAPENTIN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.