Drug Approval Package

Opana (Oxymorphone Hydrochloride) Extended-Release Tablets
Company: Endo Pharmaceuticals
Application No.:  021610 & 021611
Approval Date: 06/22/2006

• Approval Letter(s) (PDF) 
  

• Approvable Letter (PDF) 

• Printed Labeling (PDF) 

• Medical Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)
  Part 4 (PDF)  
  Part 5 (PDF)  
  Part 6 (PDF)
  Part 7 (PDF)  
  Part 8 (PDF)  

• Chemistry Review(s) (PDF) 

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

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

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 

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

Date created: October 3, 2008

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