ANDA 205446, held by Pharmazone. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 205446 (Memantine Hydrochloride), held by Pharmazone, was first approved by FDA on Dec 7, 2015, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 7, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Memantine Hydrochloride2MG/ML ยท solution;oral | Memantine Hydrochloride | Discontinued |
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
