ANDA 201634, held by Indicus Pharma. Donepezil Hydrochloride.
As of Nov 15, 2026, ANDA 201634 (Donepezil Hydrochloride), held by Indicus Pharma, was first approved by FDA on Jun 13, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 13, 2011 | Original application | Approved | None posted |
| Donepezil Hydrochloride5MG · tablet;oral | Donepezil Hydrochloride | Discontinued |
| Donepezil Hydrochloride10MG · tablet;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
