Treats moderate to severe dementia of the Alzheimer's type. ANDA 90051, held by Lupin. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 90051 (Memantine Hydrochloride), held by Lupin, was first approved by FDA on Apr 10, 2015, with 1 approved supplement and 0 published complete response letters.
Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 10, 2015 | Original application | Approved |
| Memantine Hydrochloride5MG · tablet;oral | Memantine Hydrochloride | Rx |
| Memantine Hydrochloride10MG · tablet;oral | Memantine Hydrochloride | Rx |
| Jun 28, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 10, 2015 | Original application | Approved |
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
