Treats moderate to severe dementia of the Alzheimer’s type. ANDA 210319, held by Pharmazone. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 210319 (Memantine Hydrochloride), held by Pharmazone, was first approved by FDA on Aug 31, 2020, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2020 | 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
