Donepezil Hydrochloride

Treats dementia of the Alzheimer’s type. ANDA 201146, held by Macleods Pharms Ltd. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 201146 (Donepezil Hydrochloride), held by Macleods Pharms Ltd, was first approved by FDA on Aug 17, 2012, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 17, 2012
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Aug 17, 2012	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 6 submissions, including labeling and manufacturing supplements


Jun 7, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Nov 13, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Nov 6, 2014	Supplement 3Manufacturing	Approved	None posted
Nov 7, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Aug 17, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201146
Drugs@FDA: Overview at FDA
Company: Macleods 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