Treats moderate to severe dementia of the Alzheimer's type. ANDA 209955, held by Apotex. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 209955 (Memantine Hydrochloride), held by Apotex, was first approved by FDA on Feb 9, 2018, with 0 approved supplements and 0 published complete response letters.
Memantine hydrochloride oral solution is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 9, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Memantine Hydrochloride2MG/ML · solution;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
