Donepezil Hydrochloride

Treats dementia of the Alzheimer’s type. ANDA 90056, held by Aurobindo. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 90056 (Donepezil Hydrochloride), held by Aurobindo, was first approved by FDA on May 31, 2011, with 4 approved supplements and 0 published complete response letters.

First approved: May 31, 2011
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Donepezil hydrochloride tablets are 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
May 31, 2011	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 5 submissions, including labeling and manufacturing supplements


May 21, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Nov 30, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Oct 26, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Jul 25, 2013	Supplement 3Labeling · Standard review	Approved	None posted
May 31, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90056
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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