Memantine Hydrochloride

ANDA 205905, held by Sun Pharm. Memantine Hydrochloride.

As of Nov 15, 2026, ANDA 205905 (Memantine Hydrochloride), held by Sun Pharm, was first approved by FDA on Sep 28, 2016, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 28, 2016
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Sep 28, 2016	Original application	Approved	Label Letter

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 3 submissions, including labeling and manufacturing supplements


Mar 15, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Mar 15, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Sep 28, 2016	Original application	Approved	Label Letter

Identifiers

Application: ANDA 205905
Drugs@FDA: Overview at FDA
Company: Sun Pharma

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