Treats dementia of the Alzheimer’s type. ANDA 203034, held by Hetero Labs Ltd V. Donepezil Hydrochloride.
As of Nov 15, 2026, ANDA 203034 (Donepezil Hydrochloride), held by Hetero Labs Ltd V, was first approved by FDA on Jan 30, 2015, with 2 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 |
|---|---|---|---|
| Jan 30, 2015 | Original application | Approved | None posted |
| Donepezil Hydrochloride5MG · tablet;oral | Donepezil Hydrochloride | Rx |
| Donepezil Hydrochloride10MG · tablet;oral | Donepezil Hydrochloride | Rx |
| Apr 2, 2025 | Supplement 10Labeling · Standard review | Approved | None posted |
| Oct 4, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 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
