Namenda

NDA 21627, held by Allergan. Memantine Hydrochloride.

As of Nov 14, 2026, NDA 21627 (Namenda), held by Allergan, was first approved by FDA on Apr 18, 2005, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 18, 2005
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Apr 18, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Namenda2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Memantine Hydrochloride	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Aug 11, 2014	Supplement 12Labeling · Standard review	Approved	Label Letter
Jul 10, 2014	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 24, 2013	Supplement 8Labeling · Standard review	Approved	Letter Label
Oct 4, 2006	Supplement 1Labeling · Standard review	Approved	Letter
Apr 19, 2006	Supplement 2Labeling · Standard review	Approved	Letter
Apr 18, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21627
Drugs@FDA: Overview at FDA
Company: Allergan

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