Drug Approval Package

Lovenox (enoxaparin sodium) Injection
Company:  Rhone-Poulenc Rorer Pharmaceuticals Inc.
Application No.:  020164/S010
Approval Date: 1/30/1998

• Approval Letter(s) (PDF)  

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

• Chemistry Review(s) (PDF)  

• Environmental Assessment (PDF)  
  Part 1 (PDF)
  Part 2 (PDF)  

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

• Microbiology Review(s) (PDF)   

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

• Correspondence (PDF)

Date created: April 24, 2003

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