Memantine Hydrochloride

Treats moderate to severe dementia of the Alzheimer’s type. ANDA 205825, held by Amneal Pharms. Memantine Hydrochloride.

As of Nov 15, 2026, ANDA 205825 (Memantine Hydrochloride), held by Amneal Pharms, was first approved by FDA on Oct 12, 2016, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 12, 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 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
Oct 12, 2016	Original application	Approved	None posted

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


Apr 25, 2025	Supplement 21Labeling · Standard review	Approved	None posted
Mar 18, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Oct 12, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 205825
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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