Treats moderate to severe dementia of the Alzheimer’s type. ANDA 90244, held by Chartwell. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 90244 (Memantine Hydrochloride), held by Chartwell, was first approved by FDA on Jul 11, 2018, with 1 approved supplement and 0 published complete response letters.
Memantine hydrochloride tablets, USP are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 2018 | Original application | Approved | None posted |
| Memantine Hydrochloride5MG · tablet;oral | Memantine Hydrochloride | Discontinued |
| Memantine Hydrochloride10MG · tablet;oral | Memantine Hydrochloride | Discontinued |
| Jun 28, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 11, 2018 | 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
