Treats dementia of the Alzheimer’s type. ANDA 202723, held by Dr Reddys. Donepezil Hydrochloride.
As of Nov 15, 2026, ANDA 202723 (Donepezil Hydrochloride), held by Dr Reddys, was first approved by FDA on Jul 24, 2013, with 3 approved supplements 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 |
|---|---|---|---|
| Jul 24, 2013 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Donepezil Hydrochloride23MG · tablet;oral | Donepezil Hydrochloride | Rx |
| May 21, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 21, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 20, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 24, 2013 | Original application | Approved |
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
