Donepezil Hydrochloride

ANDA 201001, held by Dr Reddys Labs Ltd. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 201001 (Donepezil Hydrochloride), held by Dr Reddys Labs Ltd, was first approved by FDA on May 31, 2011, with 3 approved supplements and 0 published complete response letters.

First approved: May 31, 2011
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 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 4 submissions, including labeling and manufacturing supplements


Nov 17, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Nov 17, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Jan 7, 2013	Supplement 3Labeling · Standard review	Approved	None posted
May 31, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 201001
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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