← FDA DRUG APPROVALS

FDA NDA · NDA021336

EMSAM

selegiline

Sponsor: SOMERSET

APPLICATION
NDA021336
TYPE
NDA
ORIGINAL APPROVAL
2006-02-27
LATEST ACTION
2017-07-14
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

EMSAM · ReferencePrescription
SELEGILINE 9MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
EMSAM · ReferencePrescription
SELEGILINE 12MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
EMSAM · ReferencePrescription
SELEGILINE 6MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2017-07-14Labeling · Supplement 14 · standard — Letter ↗AP
2015-10-16Manufacturing (CMC) · Supplement 12 · standardAP
2015-03-27Labeling · Supplement 11 · standard — Letter ↗AP
2014-09-10Labeling · Supplement 5 · standard — Letter ↗AP
2014-09-10Efficacy · Supplement 10 · standard — Pediatric Medical Review ↗AP
2008-02-13Labeling · Supplement 1 · standard — Letter ↗AP
2007-07-30Labeling · Supplement 2 · standard — Label ↗AP
2006-02-27Type 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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