Drug Approval Package

Emsam (Selegiline) Transdermal System
Company: Somerset Pharmaceuticals, Inc.
Application No.:  021336 & 021708
Approval Date: 02/27/2006

• Approval Letter(s) (PDF)  

• Approvable Letter (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created:  September 10, 2007

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