Donepezil Hydrochloride

ANDA 91198, held by Aiping Pharm Inc. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 91198 (Donepezil Hydrochloride), held by Aiping Pharm Inc, was first approved by FDA on May 10, 2011, with 3 approved supplements and 0 published complete response letters.

First approved: May 10, 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 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 4 submissions, including labeling and manufacturing supplements


Dec 19, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Nov 17, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Nov 17, 2016	Supplement 8Labeling · Standard review	Approved	None posted
May 10, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91198
Drugs@FDA: Overview at FDA
Company: Aiping Pharmaceutical

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