Memantine Hydrochloride

Treats moderate to severe dementia of the Alzheimer's type. ANDA 206028, held by Lupin. Memantine Hydrochloride.

As of Nov 15, 2026, ANDA 206028 (Memantine Hydrochloride), held by Lupin, 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

What It's For

From the FDA-approved label (Indications and Usage)

Memantine hydrochloride extended-release capsules are a N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type.

Full prescribing information on DailyMed ↗

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	Rx
Memantine Hydrochloride14MG · capsule, extended release;oral	Memantine Hydrochloride	Rx
Memantine Hydrochloride21MG · capsule, extended release;oral	Memantine Hydrochloride	Rx
Memantine Hydrochloride28MG · capsule, extended release;oral	Memantine Hydrochloride	Rx

All 3 submissions, including labeling and manufacturing supplements


Jun 2, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Jun 2, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Sep 28, 2016	Original application	Approved	Label Letter

Identifiers

Application: ANDA 206028
Drugs@FDA: Overview at FDA
Company: Lupin

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