Memantine Hydrochloride

Treats moderate to severe dementia of the Alzheimer's type. ANDA 200022, held by Unichem. Memantine Hydrochloride.

As of Nov 15, 2026, ANDA 200022 (Memantine Hydrochloride), held by Unichem, was first approved by FDA on Oct 13, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 13, 2015
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Memantine hydrochloride tablets are an N-methyl-D-asparate (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 2 submissions below

Date	Submission	Status	Documents
Oct 13, 2015	Original application	Approved	None posted

Products

2 strengths and forms


Memantine Hydrochloride5MG · tablet;oral	Memantine Hydrochloride	Rx
Memantine Hydrochloride10MG · tablet;oral	Memantine Hydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Apr 24, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Oct 13, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 200022
Drugs@FDA: Overview at FDA
Company: Unichem Laboratories

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