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)
-
Chemistry Review(s) (PDF)
-
Statistical Review(s) (PDF)
-
Microbiology Review(s) (PDF)
-
Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF)
Date created: September 10, 2007
Note: Documents in PDF format require the Adobe Acrobat Reader®.