Treats moderate to severe dementia of the Alzheimer’s type. ANDA 204033, held by Chartwell Molecular. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 204033 (Memantine Hydrochloride), held by Chartwell Molecular, was first approved by FDA on Oct 13, 2015, 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 |
|---|---|---|---|
| Oct 13, 2015 | 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
