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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021336
Company: SOMERSET

Medication Guide

Other Important Information from FDA

Products on NDA 021336

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMSAM	SELEGILINE	6MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	Yes
EMSAM	SELEGILINE	9MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	No
EMSAM	SELEGILINE	12MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021336

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 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021708s000_021336s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021708s000_021336s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021336s000_021708s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2017	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021336s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021336Orig1s014ltr.pdf
10/16/2015	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/27/2015	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021336s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021336Orig1s011ltr.pdf
09/10/2014	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021336Orig1s005,s010,021708Orig1s000ltr.pdf
09/10/2014	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021336s005s010,021708s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021336Orig1s005,s010,021708Orig1s000ltr.pdf
07/30/2007	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021336s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021336s002ltr.pdf
02/13/2008	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021336s001ltr.pdf

Labels for NDA 021336

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2017	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021336s014lbl.pdf
03/27/2015	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021336s011lbl.pdf
03/27/2015	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021336s011lbl.pdf
03/27/2015	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021336s011lbl.pdf
09/10/2014	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021336s005s010,021708s000lbl.pdf
07/30/2007	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021336s002lbl.pdf
02/27/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021708s000_021336s000lbl.pdf

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