Donepezil Hydrochloride

Treats dementia of the Alzheimer’s type. ANDA 202631, held by Macleods Pharms. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 202631 (Donepezil Hydrochloride), held by Macleods Pharms, was first approved by FDA on Jan 22, 2014, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 22, 2014
Supplements approved: 3
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 4 submissions below

Date	Submission	Status	Documents
Jan 22, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Donepezil Hydrochloride23MG · tablet;oral	Donepezil Hydrochloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Nov 13, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Sep 22, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Jan 22, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202631
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