Donepezil Hydrochloride

Treats dementia of the Alzheimer's type. ANDA 90686, held by Torrent Pharms. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 90686 (Donepezil Hydrochloride), held by Torrent Pharms, 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 an acetylcholinesterase inhibitor 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 20, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Sep 28, 2017	Supplement 5Labeling · Standard review	Approved	None posted
Jul 20, 2015	Supplement 3Labeling · Standard review	Approved	None posted
May 1, 2015	Supplement 4Manufacturing	Approved	None posted
May 31, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90686
Drugs@FDA: Overview at FDA
Company: Torrent 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