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Data updated: Mar 10, 2026

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE
Neurology Approved 2017-01-27
3
Indications
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2017-01-27
Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE Approval History

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What MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE Treats

1 indications

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Alzheimer's Disease
Source: FDA Label
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Ongoing clinical trials by development phase

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Key Completed Trials

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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 AND DONEPEZIL HYDROCHLORIDE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Memantine and donepezil hydrochlorides extended-release capsules is indicated for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on 10 mg of donepezil hydrochloride once daily. Memantine and donepezil hydrochlorides extended-release capsules is a combination of memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on 10 mg of donepezil hydrochloride once daily.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.