Namenda Xr

NDA 22525, held by Abbvie. Memantine Hydrochloride.

As of Nov 13, 2026, NDA 22525 (Namenda Xr), held by Abbvie, was first approved by FDA on Jun 21, 2010, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 21, 2010
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Jul 3, 2014	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 21, 2010	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

4 strengths and forms


Namenda Xr7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Memantine Hydrochloride	DiscontinuedReference drug
Namenda Xr14MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Memantine Hydrochloride	DiscontinuedReference drug
Namenda Xr21MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Memantine Hydrochloride	DiscontinuedReference drug
Namenda Xr28MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Memantine Hydrochloride	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements


Nov 22, 2019	Supplement 15Labeling · Standard review	Approved	Label Letter
Jan 6, 2017	Supplement 12Manufacturing	Approved	None posted
May 17, 2016	Supplement 9Manufacturing · Standard review	Approved	None posted
May 18, 2015	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 26, 2014	Supplement 6Labeling · Standard review	Approved	Letter Label
Sep 9, 2014	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 3, 2014	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 14, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 20, 2013	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 21, 2010	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22525
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