Donepezil Hydrochloride

ANDA 202410, held by Hisun Pharm Hangzhou. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 202410 (Donepezil Hydrochloride), held by Hisun Pharm Hangzhou, was first approved by FDA on Mar 24, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 24, 2017
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
Mar 24, 2017	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 5, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Mar 24, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 202410
Drugs@FDA: Overview at FDA
Company: Hisun Pharmaceutical (Hangzhou)

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