NDA 212304, held by Corium. Donepezil Hydrochloride.
As of Nov 13, 2026, NDA 212304 (Adlarity), held by Corium, was first approved by FDA on Mar 11, 2022, with 0 approved supplements and 1 published complete response letter.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 11, 2022 | Original applicationNew dosage form · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jul 23, 2020 | ADLARITY (donepezil transdermal system) | Approved |
| Adlarity5MG/DAY · system;transdermal | Donepezil Hydrochloride | DiscontinuedReference drug |
| Adlarity10MG/DAY · system;transdermal | Donepezil Hydrochloride | DiscontinuedReference drug |
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
