Donepezil Hydrochloride

ANDA 202542, held by Ph Health. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 202542 (Donepezil Hydrochloride), held by Ph Health, was first approved by FDA on Jul 24, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 24, 2013
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 24, 2013	Original application	Approved	Letter

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Dec 23, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Dec 23, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Jul 24, 2013	Original application	Approved	Letter

Identifiers

Application: ANDA 202542
Drugs@FDA: Overview at FDA
Company: PH Health

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