Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021708
Company: SOMERSET

• Medication Guide

• Other Important Information from FDA

Products on NDA 021708

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMSAM	SELEGILINE	6MG	SYSTEM; TRANSDERMAL	Prescription	None	No	No
EMSAM	SELEGILINE	9MG	SYSTEM; TRANSDERMAL	Prescription	None	No	No
EMSAM	SELEGILINE	12MG	SYSTEM; TRANSDERMAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021708

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2006	ORIG-1	Approval	Type 6 - New Indication (no longer used)	STANDARD	Label (PDF) Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021708s000_021336s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021336s005s010,021708s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021708s000_021336s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021336Orig1s005,s010,021708Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021336s000_021708s000TOC.cfm

Labels for NDA 021708

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021336s005s010,021708s000lbl.pdf
02/27/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021708s000_021336s000lbl.pdf