Data updated: Mar 10, 2026
DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE
Approved 2009-12-11
29
Indications
--
Phase 3 Trials
16
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2009-12-11
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, ORALLY DISINTEGRATING
Companies
Sun Pharma PAR PHARM CHARTWELL RX AIPING PHARM INC PRINSTON INC MACLEODS PHARMS LTD SCIEGEN PHARMS UNICHEM NOVITIUM PHARMA TORRENT PHARMS ACCORD HLTHCARE ALEMBIC PHARMS LTD DEXCEL HERITAGE PHARMA ZYDUS PHARMS USA INC HISUN PHARM HANGZHOU CADILA PHARMS LTD JUBILANT GENERICS INDICUS PHARMA OSMOTICA PHARM US STRIDES PHARMA WOCKHARDT HETERO LABS LTD V ZYDUS PHARMS Cipla Apotex NATCO PHARMA RISING Aurobindo Pharma ZYDUS LIFESCIENCES Teva Hikma Dr. Reddy's PH HEALTH Lupin TWI PHARMS
Active Ingredient: DONEPEZIL HYDROCHLORIDE
Website: ↗
DONEPEZIL HYDROCHLORIDE Approval History
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What DONEPEZIL HYDROCHLORIDE Treats
29 FDA approvalsOriginally approved for its first indication in 2009 . Covers 29 distinct patient populations.
- Other (29)
Other
(29 approvals)- • Approved indication (Dec 2009)Label Letter
- • Approved indication (Nov 2010)Letter
- • Approved indication (May 2011)
- • Approved indication (May 2011)
- • Approved indication (Jun 2011)
- • Approved indication (Jun 2011)
- • Approved indication (Aug 2011)
- • Approved indication (Aug 2012)
- • Approved indication (Oct 2012)
- • Approved indication (Dec 2012)
- • Approved indication (Feb 2013)
- • Approved indication (Jul 2013)
- • Approved indication (Jul 2013)Letter
- • Approved indication (Jan 2014)
- • Approved indication (Oct 2014)
- • Approved indication (Jan 2015)
- • Approved indication (Jun 2015)
- • Approved indication (Oct 2015)
- • Approved indication (Oct 2015)
- • Approved indication (Dec 2015)
- • Approved indication (Jan 2016)
- • Approved indication (Feb 2016)
- • Approved indication (Apr 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Nov 2016)
- • Approved indication (Mar 2017)
- • Approved indication (Aug 2017)
- • Approved indication (Sep 2017)
- • Approved indication (Jul 2018)
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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.
DONEPEZIL 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.