FDA NDA · NDA021487

MEMANTINE HYDROCHLORIDE

Sponsor: ABBVIE

APPLICATION

NDA021487

TYPE

NDA

ORIGINAL APPROVAL

2003-10-16

LATEST ACTION

2018-11-02

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

NAMENDA · ReferenceDiscontinued

MEMANTINE HYDROCHLORIDE 10MG · TABLET · ORAL

NAMENDA · ReferenceDiscontinued

MEMANTINE HYDROCHLORIDE 5MG · TABLET · ORAL

2018-11-02Labeling · Supplement 25 · standard — Label ↗AP

2016-05-18Manufacturing (CMC) · Supplement 22 · standardAP

2016-03-07Manufacturing (CMC) · Supplement 21 · standardAP

2015-04-29Manufacturing (CMC) · Supplement 20 · standardAP

2013-11-14Manufacturing (CMC) · Supplement 18 · standardAP

2013-10-24Labeling · Supplement 14 · standard — Label ↗AP

2013-10-24Labeling · Supplement 12 · standard — Letter ↗AP

2013-10-24Labeling · Supplement 10 · standard — Label ↗AP

2013-03-11Manufacturing (CMC) · Supplement 17 · standardAP

2006-10-04Labeling · Supplement 8 · standard — Letter ↗AP

2006-04-19Labeling · Supplement 7 · standard — Letter ↗AP

2005-05-17Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP

2005-05-02Labeling · Supplement 4 · standard — Letter ↗AP

2004-09-22Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP

2003-10-16Type 1 - New Molecular Entity · Original · standard — Review ↗AP

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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