Data updated: Mar 10, 2026
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE
Approved 2002-01-24
87
Indications
--
Phase 3 Trials
24
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2002-01-24
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET, SOLUTION
Companies
WATSON LABS INC Aurobindo Pharma QINGDAO BAHEAL PHARM YICHANG HUMANWELL GRANULES AJANTA PHARMA LTD SCIEGEN PHARMS WATSON LABS IMPAX LABS Dr. Reddy's MEDICAP LABS ALIGNSCIENCE PHARMA HARMAN FINOCHEM PHARMOBEDIENT ZYDUS PHARMS USA RANBAXY LABS LTD AMNEAL PHARMS NY TORRENT MARKSANS PHARMA CSPC OUYI TWI PHARMS Apotex UNICHEM Teva Sun Pharma GRANULES INDIA LAURUS GLENMARK PHARMS LTD SENORES PHARMS Novartis IVAX SUB TEVA PHARMS INDICUS PHARMA Lupin SAPTALIS PHARMS UTOPIC PHARMS ZYDUS LIFESCIENCES TORRENT PHARMS LTD Viatris ALKEM LABS LTD PRINSTON INC RK PHARMA HERITAGE PHARMA TORRENT PHARMS PROVIDENT PHARM IPCA LABS LTD ALKEM INVENTIA ZYDUS HLTHCARE ANNORA PHARMA WATSON LABS FLORIDA SUNSHINE VISTAPHARM LLC BIONPHARMA MPP PHARMA MACLEODS PHARMS LTD NOVAST LABS EPIC PHARMA LLC CHARTWELL NOSTRUM PHARMS LLC AARXION ANDA HLDING REGCON HOLDINGS MICRO LABS
Active Ingredient: METFORMIN HYDROCHLORIDE
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METFORMIN HYDROCHLORIDE Approval History
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What METFORMIN HYDROCHLORIDE Treats
87 FDA approvalsOriginally approved for its first indication in 2002 . Covers 87 distinct patient populations.
- Other (87)
Other
(87 approvals)- • Approved indication (Jan 2002)
- • Approved indication (Jan 2002)
- • Approved indication (Jan 2002)
- • Approved indication (Feb 2002)Letter
- • Approved indication (Apr 2002)
- • Approved indication (Dec 2002)
- • Approved indication (Dec 2003)
- • Approved indication (Jun 2004)
- • Approved indication (Jun 2004)Letter
- • Approved indication (Jul 2004)
- • Approved indication (Oct 2004)
- • Approved indication (Oct 2004)Letter
- • Approved indication (Dec 2004)
- • Approved indication (Jan 2005)
- • Approved indication (Apr 2005)
- • Approved indication (Apr 2005)
- • Approved indication (Apr 2005)
- • Approved indication (Apr 2005)
- • Approved indication (Apr 2005)
- • Approved indication (Jun 2005)
- • Approved indication (Sep 2005)
- • Approved indication (Sep 2005)
- • Approved indication (Nov 2005)
- • Approved indication (Dec 2005)
- • Approved indication (Feb 2006)
- • Approved indication (Jun 2006)
- • Approved indication (Jul 2006)
- • Approved indication (Jul 2006)
- • Approved indication (Aug 2006)
- • Approved indication (Jan 2007)
- • Approved indication (Aug 2007)
- • Approved indication (Jan 2008)
- • Approved indication (Apr 2008)
- • Approved indication (May 2008)
- • Approved indication (Nov 2008)
- • Approved indication (Dec 2009)
- • Approved indication (Feb 2010)
- • Approved indication (Apr 2010)
- • Approved indication (Nov 2010)
- • Approved indication (Jun 2011)
- • Approved indication (Dec 2011)
- • Approved indication (Jan 2012)
- • Approved indication (Mar 2012)
- • Approved indication (Jul 2012)
- • Approved indication (Aug 2012)
- • Approved indication (Jul 2013)Label Letter
- • Approved indication (Sep 2013)
- • Approved indication (Aug 2014)
- • Approved indication (Apr 2016)
- • Approved indication (Jul 2016)Letter
- • Approved indication (Aug 2016)
- • Approved indication (Dec 2016)
- • Approved indication (Dec 2016)
- • Approved indication (Feb 2017)Letter
- • Approved indication (Oct 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Mar 2018)
- • Approved indication (Mar 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Sep 2018)
- • Approved indication (Sep 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Nov 2019)
- • Approved indication (Mar 2020)
- • Approved indication (Apr 2020)
- • Approved indication (Jan 2021)
- • Approved indication (Mar 2021)
- • Approved indication (Apr 2021)
- • Approved indication (Aug 2021)
- • Approved indication (Aug 2021)
- • Approved indication (Sep 2021)
- • Approved indication (Dec 2021)
- • Approved indication (Dec 2021)
- • Approved indication (Feb 2022)
- • Approved indication (Jun 2022)
- • Approved indication (Aug 2022)
- • Approved indication (Jan 2023)
- • Approved indication (Jun 2023)
- • Approved indication (Oct 2023)
- • Approved indication (Mar 2024)
- • Approved indication (Jul 2024)
- • Approved indication (Oct 2024)
- • Approved indication (Mar 2025) New
- • Approved indication (Apr 2025) New
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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.
METFORMIN 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.