Memantine Hydrochloride

Treats moderate to severe dementia of the Alzheimer's type. ANDA 213985, held by H2-Pharma. Memantine Hydrochloride.

As of Nov 15, 2026, ANDA 213985 (Memantine Hydrochloride), held by H2-Pharma, was first approved by FDA on Oct 11, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 11, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Memantine hydrochloride extended-release capsules is 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 11, 2022	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 Hydrochloride28MG · capsule, extended release;oral	Memantine Hydrochloride	Rx
Memantine Hydrochloride21MG · capsule, extended release;oral	Memantine Hydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Feb 6, 2024	Supplement 1Manufacturing	Approved	None posted
Oct 11, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 213985
Drugs@FDA: Overview at FDA
Company: H2-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