Treats moderate to severe dementia of the Alzheimer’s type. ANDA 212947, held by Pharmobedient. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 212947 (Memantine Hydrochloride), held by Pharmobedient, was first approved by FDA on Apr 3, 2020, with 1 approved supplement and 0 published complete response letters.
Memantine Hydrochloride Tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 3, 2020 | Original application | Approved | None posted |
| Memantine Hydrochloride5MG · tablet;oral | Memantine Hydrochloride | Rx |
| Memantine Hydrochloride10MG · tablet;oral | Memantine Hydrochloride | Rx |
| May 17, 2024 | Supplement 1Manufacturing | Approved | None posted |
| Apr 3, 2020 | 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
