Drug Approval Package

Altocor (lovastatin) Extended-Release Tablets
Company:  Aura Laboratories
Application No.:  021316
Approval Date: 6/26/2002

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  
  

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

• Chemistry Review(s) (PDF)  

• Environmental Assessment (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)  
  Part 8 (PDF)  
  Part 9 (PDF)  

• Statistical Review(s) (PDF)  
  

• Microbiology Review(s) (PDF)   
  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  
  

• Administrative Document(s) (PDF)  
  Part 1 (PDF)  
  Part 2 (PDF)  
  

• Correspondence (PDF)

Date created: April 30, 2003

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