Drug Approval Package

Nebivolol Tablets
Company: Mylan Bertek Pharmaceuticals
Application No.: 021742
Approval Date: 12/17/2007

• Approval Letter(s) (PDF) 
  

• Approvable Letter (PDF) 

• Printed Labeling (PDF) 

• Summary Review (PDF) 
• Officer/Employee List (PDF) 
• Medical Review(s) (PDF) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)
  Part 4 (PDF)  
  Part 5 (PDF)  
  Part 6 (PDF)
  Part 7 (PDF)  
  Part 8 (PDF)  
  Part 9 (PDF)
  Part 10 (PDF)  
  Part 11 (PDF)  
  Part 12 (PDF)

• Chemistry Review(s) (PDF) 

• Pharmacology Review(s) (PDF) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)
  Part 4 (PDF)  
  Part 5 (PDF)  
  Part 6 (PDF)
  Part 7 (PDF)  

• Statistical Review(s) (PDF) 

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)

• Proprietary Name Review(s) (PDF) 
• Administrative Document(s) & Correspondence(PDF) 
  Part 1 (PDF)  
  Part 2 (PDF)  

Date created: May 2, 2008; updated June 25, 2008

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