Aricept Odt

NDA 21720, held by Eisai Inc. Donepezil Hydrochloride.

As of Nov 14, 2026, NDA 21720 (Aricept Odt), held by Eisai Inc, was first approved by FDA on Oct 18, 2004, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 18, 2004
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Oct 13, 2006	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 18, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Aricept Odt5MG · tablet, orally disintegrating;oral	Donepezil Hydrochloride	DiscontinuedReference drug
Aricept Odt10MG · tablet, orally disintegrating;oral	Donepezil Hydrochloride	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


Dec 18, 2018	Supplement 14Labeling · Standard review	Approved	Letter Label
Jul 20, 2015	Supplement 12Labeling · Standard review	Approved	Label Letter
Sep 6, 2013	Supplement 10Labeling · Standard review	Approved	Letter Label
Apr 4, 2013	Supplement 7Labeling · Standard review	Approved	Letter
Sep 4, 2012	Supplement 9Labeling · Standard review	Approved	Label Letter
Mar 7, 2012	Supplement 8Labeling · Standard review	Approved	Label Letter
Dec 2, 2010	Supplement 6Labeling · Standard review	Approved	Label Letter
Oct 13, 2006	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 18, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21720
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