Donepezil Hydrochloride

ANDA 90521, held by Natco Pharma. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 90521 (Donepezil Hydrochloride), held by Natco Pharma, 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

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	Discontinued
Donepezil Hydrochloride10MG · tablet;oral	Donepezil Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


May 4, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Jan 3, 2017	Supplement 5Labeling · Standard review	Approved	None posted
Feb 25, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Apr 22, 2013	Supplement 1Labeling · Standard review	Approved	None posted
May 31, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90521
Drugs@FDA: Overview at FDA
Company: Natco 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