Namenda

Treats moderate to severe dementia of the Alzheimer’s type. NDA 21487, held by Abbvie. Memantine Hydrochloride.

As of Nov 14, 2026, NDA 21487 (Namenda), held by Abbvie, was first approved by FDA on Oct 16, 2003, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 16, 2003
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Memantine hydrochloride tablets 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 15 submissions below

Date	Submission	Status	Documents
Oct 16, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Namenda5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Memantine Hydrochloride	DiscontinuedReference drug
Namenda10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Memantine Hydrochloride	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Nov 2, 2018	Supplement 25Labeling · Standard review	Approved	Letter Label
May 18, 2016	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 7, 2016	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 29, 2015	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 14, 2013	Supplement 18Manufacturing · Standard review	Approved	None posted
Oct 24, 2013	Supplement 10Labeling · Standard review	Approved	Letter Label
Oct 24, 2013	Supplement 12Labeling · Standard review	Approved	Letter Label
Oct 24, 2013	Supplement 14Labeling · Standard review	Approved	Label Letter
Mar 11, 2013	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 4, 2006	Supplement 8Labeling · Standard review	Approved	Letter
Apr 19, 2006	Supplement 7Labeling · Standard review	Approved	Letter
May 17, 2005	Supplement 6Manufacturing · Standard review	Approved	Letter
May 2, 2005	Supplement 4Labeling · Standard review	Approved	Letter
Sep 22, 2004	Supplement 2Manufacturing · Standard review	Approved	Letter
Oct 16, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21487
Drugs@FDA: Overview at FDA
Company: AbbVie

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