Donepezil Hydrochloride

ANDA 203162, held by Zydus Pharms. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 203162 (Donepezil Hydrochloride), held by Zydus Pharms, was first approved by FDA on Aug 31, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 31, 2017
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 31, 2017	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Sep 20, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Aug 31, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 203162
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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