Treats dementia of the Alzheimer's type. ANDA 203656, held by Unichem. Donepezil Hydrochloride.
As of Nov 15, 2026, ANDA 203656 (Donepezil Hydrochloride), held by Unichem, was first approved by FDA on Jun 23, 2016, with 1 approved supplement and 0 published complete response letters.
Donepezil hydrochloride is an acetylcholinesterase inhibitor 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 |
|---|---|---|---|
| Jun 23, 2016 | Original application | Approved | None posted |
| Donepezil Hydrochloride5MG · tablet;oral | Donepezil Hydrochloride | Discontinued |
| Donepezil Hydrochloride10MG · tablet;oral | Donepezil Hydrochloride | Discontinued |
| May 20, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 23, 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
