Donepezil Hydrochloride

ANDA 202415, held by Actavis Elizabeth. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 202415 (Donepezil Hydrochloride), held by Actavis Elizabeth, was first approved by FDA on Dec 17, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 17, 2015
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
Dec 17, 2015	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


Sep 20, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Dec 17, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 202415
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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