Treats dementia of the Alzheimer's type. ANDA 204831, held by Unichem. Donepezil Hydrochloride.
As of Nov 15, 2026, ANDA 204831 (Donepezil Hydrochloride), held by Unichem, was first approved by FDA on Nov 10, 2016, with 0 approved supplements 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 |
|---|---|---|---|
| Nov 10, 2016 | Original application | Approved | None posted |
| Donepezil Hydrochloride5MG · tablet, orally disintegrating;oral | Donepezil Hydrochloride | Discontinued |
| Donepezil Hydrochloride10MG · tablet, orally disintegrating;oral | Donepezil Hydrochloride | Discontinued |
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
