Drug Approval Package

Doribax (Doripenem) Injection
Company: Johnson & Johnson Pharmaceutical Research & Development, LLC
Application No.:  022106
Approval Date: 10/12/2007

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Summary Review (PDF)  

• Office Employee List (PDF)  

• Office Director Memo (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) (PDF)  

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

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

• Proprietary Name Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: March 14, 2008

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