Treats dementia of the Alzheimer’s type. NDA 22568, held by Eisai Inc. Donepezil Hydrochloride.
As of Nov 14, 2026, NDA 22568 (Aricept), held by Eisai Inc, was first approved by FDA on Jul 23, 2010, with 6 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 2010 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aricept23MG · tablet;oral | Donepezil Hydrochloride | RxReference drug |
| Dec 18, 2018 | Supplement 11Labeling · Standard review | Approved | |
| Jul 20, 2015 | Supplement 8Labeling · Standard review | Approved | |
| Sep 6, 2013 | Supplement 7Labeling · Standard review | Approved | |
| Sep 4, 2012 | Supplement 6Labeling · Standard review | Approved | |
| Mar 7, 2012 | Supplement 5Labeling · Standard review | Approved | |
| Dec 2, 2010 | Supplement 4Labeling · Standard review | Approved | |
| Jul 23, 2010 | Original applicationNew dosage form · Standard review | Approved |
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
