Treats moderate to severe dementia of the Alzheimer’s type. ANDA 204389, held by Hetero Labs Ltd V. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 204389 (Memantine Hydrochloride), held by Hetero Labs Ltd V, was first approved by FDA on Sep 26, 2022, with 0 approved supplements 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 |
|---|---|---|---|
| Sep 26, 2022 | Original application | Approved | None posted |
| Memantine Hydrochloride5MG · tablet;oral | Memantine Hydrochloride | Rx |
| Memantine Hydrochloride10MG · tablet;oral | Memantine Hydrochloride | Rx |
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
