Memantine Hydrochloride

ANDA 206135, held by Apotex. Memantine Hydrochloride.

As of Nov 15, 2026, ANDA 206135 (Memantine Hydrochloride), held by Apotex, was first approved by FDA on Nov 22, 2016, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 22, 2016
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 22, 2016	Original application	Approved	None posted

Products

4 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Aug 13, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Nov 22, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 206135
Drugs@FDA: Overview at FDA
Company: Apotex

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