Treats moderate to severe dementia of the Alzheimer’s type. ANDA 202840, held by Macleods Pharms Ltd. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 202840 (Memantine Hydrochloride), held by Macleods Pharms Ltd, was first approved by FDA on Oct 13, 2015, with 2 approved supplements and 0 published complete response letters.
Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 13, 2015 | Original application | Approved |
| Memantine Hydrochloride5MG · tablet;oral | Memantine Hydrochloride | Rx |
| Memantine Hydrochloride10MG · tablet;oral | Memantine Hydrochloride | Rx |
| Jun 7, 2023 | Supplement 21Labeling · Standard review | Approved | None posted |
| Jun 28, 2019 | Supplement 9Labeling · Standard review | Approved | None posted |
| Oct 13, 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
