Treats moderate to severe dementia of the Alzheimer's type. ANDA 200891, held by Alembic. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 200891 (Memantine Hydrochloride), held by Alembic, was first approved by FDA on Oct 13, 2015, with 1 approved supplement and 0 published complete response letters.
Memantine hydrochloride is indiacted for the treatment of moderate to severe dementia of the Alzheimer's type. 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 |
|---|---|---|---|
| Oct 13, 2015 | Original application | Approved | None posted |
| Memantine Hydrochloride5MG · tablet;oral | Memantine Hydrochloride | Rx |
| Memantine Hydrochloride10MG · tablet;oral | Memantine Hydrochloride | Rx |
| May 31, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 13, 2015 | 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
