Donepezil Hydrochloride

Treats dementia of the Alzheimer’s type. ANDA 201724, held by Alembic Pharms Ltd. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 201724 (Donepezil Hydrochloride), held by Alembic Pharms Ltd, was first approved by FDA on Feb 25, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 25, 2013
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease. Donepezil hydrochloride is an acetylcholinesterase inhibitor

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Feb 25, 2013	Original application	Approved	None posted

Products

2 strengths and forms


Donepezil Hydrochloride5MG · tablet;oral	Donepezil Hydrochloride	Rx
Donepezil Hydrochloride10MG · tablet;oral	Donepezil Hydrochloride	Rx

All 3 submissions, including labeling and manufacturing supplements


May 21, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Oct 4, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Feb 25, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 201724
Drugs@FDA: Overview at FDA
Company: Alembic Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters