Drug Approval Package

Chirocaine (Levobupivacaine) Injection
Company:  Purdue Pharma L.P.
Application No.:  20997
Approval Date: 8/5/1999

• Approval Letter(s) (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) (PDF)  

• Statistical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  

• Microbiology Review(s) (PDF)   

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

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

• Correspondence (PDF)  

Date created: July 24, 2002

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