Aricept

Treats dementia of the Alzheimer’s type. NDA 20690, held by Eisai Inc. Donepezil Hydrochloride.

As of Nov 13, 2026, NDA 20690 (Aricept), held by Eisai Inc, was first approved by FDA on Nov 25, 1996, with 24 approved supplements and 0 published complete response letters.

First approved: Nov 25, 1996
Review: Priority
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ARICEPT is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Oct 13, 2006	Supplement 26Efficacy (new indication or use)	Approved	Letter Label
Nov 25, 1996	Original applicationNew molecular entity · Priority review	Approved	Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Aricept10MG · tablet;oral	Donepezil Hydrochloride	RxReference drug
Aricept5MG · tablet;oral	Donepezil Hydrochloride	RxReference drug

All 25 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 18, 2018	Supplement 42Labeling · Standard review	Approved	Letter Label
Jul 20, 2015	Supplement 39Labeling · Standard review	Approved	Letter Label
Sep 6, 2013	Supplement 37Labeling · Standard review	Approved	Letter Label
Apr 4, 2013	Supplement 31Labeling · Standard review	Approved	Letter
Sep 4, 2012	Supplement 36Labeling · Standard review	Approved	Label Letter
Mar 7, 2012	Supplement 35Labeling · Standard review	Approved	Label Letter
Dec 2, 2010	Supplement 33Labeling · Standard review	Approved	Label Letter
Oct 13, 2006	Supplement 26Efficacy (new indication or use)	Approved	Letter Label
May 4, 2004	Supplement 11Labeling · Standard review	Approved	Review Letter
Jan 7, 2002	Supplement 18Manufacturing · Priority review	Approved	None posted
Jan 7, 2002	Supplement 19Manufacturing · Priority review	Approved	None posted
Oct 3, 2001	Supplement 17Manufacturing · Priority review	Approved	None posted
Jun 20, 2001	Supplement 16Labeling · Standard review	Approved	None posted
Sep 21, 2000	Supplement 15Manufacturing · Priority review	Approved	None posted
Mar 28, 2000	Supplement 13Manufacturing · Priority review	Approved	None posted
Feb 28, 2000	Supplement 8Labeling · Standard review	Approved	None posted
Feb 28, 2000	Supplement 12Labeling · Standard review	Approved	None posted
Aug 18, 1999	Supplement 10Manufacturing · Priority review	Approved	None posted
Feb 10, 1999	Supplement 9Manufacturing · Priority review	Approved	None posted
Nov 4, 1998	Supplement 7Manufacturing · Priority review	Approved	None posted
Oct 16, 1998	Supplement 6Manufacturing · Priority review	Approved	None posted
Aug 18, 1998	Supplement 5Labeling · Standard review	Approved	None posted
Aug 13, 1998	Supplement 3Manufacturing · Priority review	Approved	None posted
Aug 13, 1998	Supplement 4Manufacturing · Priority review	Approved	None posted
Nov 25, 1996	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 20690
Drugs@FDA: Overview at FDA
Company: Eisai

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