Donepezil Hydrochloride

Treats dementia of the Alzheimer’s type. ANDA 201787, held by Macleods Pharms Ltd. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 201787 (Donepezil Hydrochloride), held by Macleods Pharms Ltd, was first approved by FDA on Dec 14, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 14, 2012
Supplements approved: 4
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 5 submissions below

Date	Submission	Status	Documents
Dec 14, 2012	Original application	Approved	None posted

Products

2 strengths and forms


Donepezil Hydrochloride5MG · tablet, orally disintegrating;oral	Donepezil Hydrochloride	Rx
Donepezil Hydrochloride10MG · tablet, orally disintegrating;oral	Donepezil Hydrochloride	Rx

All 5 submissions, including labeling and manufacturing supplements


Jun 7, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Nov 13, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Apr 23, 2015	Supplement 2Manufacturing	Approved	None posted
Dec 14, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201787
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