ANDA 201335, held by Accord Hlthcare. Donepezil Hydrochloride.
As of Nov 15, 2026, ANDA 201335 (Donepezil Hydrochloride), held by Accord Hlthcare, was first approved by FDA on Aug 29, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 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
