Treats dementia of the Alzheimer's type. ANDA 202782, held by Lupin. Donepezil Hydrochloride.
As of Nov 15, 2026, ANDA 202782 (Donepezil Hydrochloride), held by Lupin, was first approved by FDA on Oct 30, 2015, with 1 approved supplement and 0 published complete response letters.
Donepezil hydrochloride tablet 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 |
|---|---|---|---|
| Oct 30, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Donepezil Hydrochloride23MG · tablet;oral | Donepezil Hydrochloride | Discontinued |
| Apr 23, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 30, 2015 | 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
