Donepezil Hydrochloride

ANDA 202656, held by Rising. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 202656 (Donepezil Hydrochloride), held by Rising, was first approved by FDA on Oct 22, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 22, 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
Oct 22, 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 5, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Oct 22, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 202656
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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