Drug Approval Package

 Azilect (Rasagiline Mesylate) Tablet
Company: Teva Pharmaceuticals
Application No.:  021641
Approval Date: 05/16/2006

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review Part 1 (PDF)

• Medical Review Part 2 (PDF)

• Medical Review Part 3 (PDF)

• Medical Review Part 4 (PDF)

• Medical Review Part 5 (PDF)

• Medical Review Part 6 (PDF)

• Medical Review Part 7 (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: July 10, 2006; updated September 21, 2006

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