Data updated: Mar 10, 2026
FAMOTIDINE
FAMOTIDINE
Approved 2001-04-16
61
Indications
--
Phase 3 Trials
24
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 2001-04-16
- Routes
- ORAL, INJECTION, Injection, INTRAVENOUS
- Dosage Forms
- TABLET, FOR SUSPENSION, INJECTABLE, Injectable, SOLUTION, TABLET, CHEWABLE
Companies
GLENMARK PHARMS INC Aurobindo Pharma MANKIND PHARMA Teva SAGENT Pfizer Dr. Reddy's CARLSBAD Apotex PERRIGO R AND D Sun Pharma Lupin NOVEL LABS INC NOVITIUM PHARMA CONTRACT PHARMACAL MICRO LABS LANNETT CO INC MARSAM PHARMS LLC PERRIGO Hikma Novartis Fresenius Kabi VKT PHARMA ASCENT PHARMS INC ZYDUS PHARMS MARKSANS PHARMA REGCON HOLDINGS WATSON LABS Viatris RISING PHARMOBEDIENT SOMERSET THERAPS LLC EPIC PHARMA LLC ANNORA PHARMA IVAX SUB TEVA PHARMS CHARTWELL RX NATCO PHARMA APOTHECON AMNEAL ALKEM LABS LTD AJANTA PHARMA LTD BIONPHARMA ALEMBIC PHARMS LTD NAVINTA LLC GRAVITI PHARMS UNICHEM P AND L MSN
Active Ingredient: FAMOTIDINE
Website: ↗
FAMOTIDINE Approval History
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What FAMOTIDINE Treats
61 FDA approvalsOriginally approved for its first indication in 2001 . Covers 61 distinct patient populations.
- Other (61)
Other
(61 approvals)- • Approved indication (Apr 2001)Letter
- • Approved indication (Apr 2001)Letter
- • Approved indication (May 2001)Letter
- • Approved indication (May 2001)Letter
- • Approved indication (Jul 2001)Label Letter
- • Approved indication (Jul 2001)
- • Approved indication (Sep 2001)Letter
- • Approved indication (Nov 2001)Letter
- • Approved indication (Nov 2001)Letter
- • Approved indication (Dec 2001)
- • Approved indication (Dec 2001)
- • Approved indication (Mar 2002)Letter
- • Approved indication (Apr 2002)
- • Approved indication (Aug 2002)
- • Approved indication (Oct 2002)Letter
- • Approved indication (Aug 2003)
- • Approved indication (Mar 2005)
- • Approved indication (Mar 2005)Letter
- • Approved indication (Jul 2005)
- • Approved indication (Sep 2006)
- • Approved indication (Jun 2008)
- • Approved indication (May 2009)
- • Approved indication (Nov 2009)
- • Approved indication (May 2010)Letter
- • Approved indication (Jun 2010)
- • Approved indication (Aug 2010)
- • Approved indication (Dec 2012)
- • Approved indication (May 2014)
- • Approved indication (Dec 2015)Letter
- • Approved indication (Apr 2016)
- • Approved indication (Apr 2021)
- • Approved indication (Oct 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Jan 2022)
- • Approved indication (Jan 2022)
- • Approved indication (Jun 2022)
- • Approved indication (Aug 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Mar 2023)
- • Approved indication (Apr 2023)
- • Approved indication (May 2023)
- • Approved indication (Jun 2023)
- • Approved indication (Jul 2023)
- • Approved indication (Aug 2023)
- • Approved indication (Sep 2023)
- • Approved indication (Sep 2023)
- • Approved indication (Dec 2023)
- • Approved indication (Dec 2023)
- • Approved indication (Jan 2024)
- • Approved indication (Mar 2024)
- • Approved indication (May 2024)
- • Approved indication (Aug 2024)
- • Approved indication (Oct 2024)
- • Approved indication (Mar 2025) New
- • Approved indication (Jun 2025) New
- • Approved indication (Jun 2025) New
- • Approved indication (Jul 2025) New
- • Approved indication (Jul 2025) NewLabel Letter
- • Approved indication (Jul 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.
FAMOTIDINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.