Donepezil Hydrochloride

ANDA 203419, held by Chartwell Rx. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 203419 (Donepezil Hydrochloride), held by Chartwell Rx, was first approved by FDA on Apr 12, 2016, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 12, 2016
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
Apr 12, 2016	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Nov 10, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Apr 12, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 203419
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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