Data updated: Mar 10, 2026
MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE
Approved 2010-04-14
32
Indications
--
Phase 3 Trials
15
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2010-04-14
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION, CAPSULE, EXTENDED RELEASE
Companies
JUBILANT GENERICS MACLEODS PHARMS LTD Sun Pharma LANNETT CO INC SOMERSET THERAPS LLC Aurobindo Pharma PH HEALTH UPSHER SMITH LABS Teva POINTVIEW HLDINGS CHARTWELL Apotex YICHANG HUMANWELL YILING STRIDES PHARMA HETERO LABS LTD V AMNEAL PHARMS NOVAST LABS LTD ALEMBIC SCIEGEN PHARMS ORBION PHARMS ZYDUS LIFESCIENCES TORRENT Lupin AJANTA PHARMA LTD Hikma RISING CHARTWELL MOLECULAR ANI PHARMS PURACAP LABS BLU Dr. Reddy's UNICHEM ZYDUS PHARMS SETON PHARMS PURACAP PHARM LLC VITRUVIAS
Active Ingredient: MEMANTINE HYDROCHLORIDE
Website: ↗
MEMANTINE HYDROCHLORIDE Approval History
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What MEMANTINE HYDROCHLORIDE Treats
32 FDA approvalsOriginally approved for its first indication in 2010 . Covers 32 distinct patient populations.
- Other (32)
Other
(32 approvals)- • Approved indication (Apr 2010)Letter
- • Approved indication (May 2010)
- • Approved indication (Oct 2011)
- • Approved indication (Mar 2012)Letter
- • Approved indication (Jan 2015)
- • Approved indication (Apr 2015)Letter
- • Approved indication (Jul 2015)Letter
- • Approved indication (Sep 2015)Letter
- • Approved indication (Oct 2015)
- • Approved indication (Nov 2015)
- • Approved indication (Nov 2015)
- • Approved indication (Dec 2015)
- • Approved indication (Sep 2016)Label Letter
- • Approved indication (Oct 2016)
- • Approved indication (Nov 2016)
- • Approved indication (Nov 2016)
- • Approved indication (May 2017)
- • Approved indication (Jun 2017)
- • Approved indication (Jul 2017)
- • Approved indication (Aug 2017)Letter
- • Approved indication (Feb 2018)
- • Approved indication (May 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Feb 2020)
- • Approved indication (Apr 2020)
- • Approved indication (Aug 2020)
- • Approved indication (Dec 2020)
- • Approved indication (Apr 2021)
- • Approved indication (Aug 2021)
- • Approved indication (Sep 2022)
- • Approved indication (Oct 2022)
- • Approved indication (Aug 2025) NewLetter
🔬
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.
MEMANTINE 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.