Treats dementia of the Alzheimer's type. ANDA 203713, held by Dexcel. Donepezil Hydrochloride.
As of Nov 15, 2026, ANDA 203713 (Donepezil Hydrochloride), held by Dexcel, was first approved by FDA on Feb 19, 2016, with 1 approved supplement and 0 published complete response letters.
Donepezil hydrochloride tablets are 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 |
|---|---|---|---|
| Feb 19, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Donepezil Hydrochloride23MG · tablet;oral | Donepezil Hydrochloride | Rx |
| Sep 20, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 19, 2016 | Original application | Approved | None posted |
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
