Donepezil Hydrochloride

ANDA 90551, held by Novitium Pharma. Donepezil Hydrochloride.

As of Nov 15, 2026, ANDA 90551 (Donepezil Hydrochloride), held by Novitium Pharma, was first approved by FDA on May 31, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: May 31, 2011
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
May 31, 2011	Original application	Approved	None posted

Products

2 strengths and forms


Donepezil Hydrochloride5MG · tablet;oral	Donepezil Hydrochloride	Rx
Donepezil Hydrochloride10MG · tablet;oral	Donepezil Hydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Mar 4, 2016	Supplement 4Labeling · Standard review	Approved	None posted
May 31, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90551
Drugs@FDA: Overview at FDA
Company: Novitium Pharma

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