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FDA NDA · NDA021627

NAMENDA

Sponsor: ALLERGAN

APPLICATION
NDA021627
TYPE
NDA
ORIGINAL APPROVAL
2005-04-18
LATEST ACTION
2014-08-11
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

NAMENDA · ReferenceDiscontinued
MEMANTINE HYDROCHLORIDE 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2014-08-11Labeling · Supplement 12 · standard — Label ↗AP
2014-07-10Manufacturing (CMC) · Supplement 11 · standardAP
2013-10-24Labeling · Supplement 8 · standard — Letter ↗AP
2006-10-04Labeling · Supplement 1 · standard — Letter ↗AP
2006-04-19Labeling · Supplement 2 · standard — Letter ↗AP
2005-04-18Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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