Drug Approval Package

 Sporanox (itraconazole) injection 10mg/ml
Company:  Janssen Research Foundation
Application No.:  020996
Approval Date: 3/30/1999

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

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

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)   

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)    

• Administrative Document(s) (PDF)    

• Correspondence (PDF)  

Date created: August 13, 2003

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