Donepezil Hydrochloride

ANDA 90175, held by Zydus Pharms USA Inc. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 90175 (Donepezil Hydrochloride), held by Zydus Pharms USA Inc, was first approved by FDA on May 10, 2011, with 4 approved supplements and 0 published complete response letters.

First approved: May 10, 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 10, 2011	Original application	Approved	None posted

Products

2 strengths and forms


Donepezil Hydrochloride5MG · tablet, orally disintegrating;oral	Donepezil Hydrochloride	Discontinued
Donepezil Hydrochloride10MG · tablet, orally disintegrating;oral	Donepezil Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jan 2, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Sep 24, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Feb 18, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Apr 22, 2013	Supplement 1Labeling · Standard review	Approved	None posted
May 10, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90175
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