NDA 21719, held by Eisai Inc. Donepezil Hydrochloride.
As of Nov 14, 2026, NDA 21719 (Aricept), held by Eisai Inc, was first approved by FDA on Oct 18, 2004, with 1 approved supplement and 0 published complete response letters.
| Oct 13, 2006 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Oct 18, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aricept5MG/5ML · solution;oral | Donepezil Hydrochloride | DiscontinuedReference drug |
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
