Treats moderate to severe dementia of the Alzheimer's type. ANDA 202790, held by Macleods Pharms. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 202790 (Memantine Hydrochloride), held by Macleods Pharms, was first approved by FDA on Oct 13, 2015, with 1 approved supplement and 0 published complete response letters.
Memantine hydrochloride solution 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 | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Memantine Hydrochloride2MG/ML · solution;oral | Memantine Hydrochloride | Rx |
| Mar 6, 2018 | Supplement 3Manufacturing | 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
