ANDA 205365, held by Ani Pharms. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 205365 (Memantine Hydrochloride), held by Ani Pharms, was first approved by FDA on Feb 28, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2020 | Original application | Approved | None posted |
| Memantine Hydrochloride7MG · capsule, extended release;oral | Memantine Hydrochloride | Discontinued |
| Memantine Hydrochloride14MG · capsule, extended release;oral | Memantine Hydrochloride | Discontinued |
| Memantine Hydrochloride21MG · capsule, extended release;oral | Memantine Hydrochloride | Discontinued |
| Memantine Hydrochloride28MG · capsule, extended release;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
