Drug Approval Package

Sporanox (Itraconazole) Injection & Oral Solution
Company:  Janssen Research Foundation
Application No.:  20-966/S1, 3 & 4 & 20-657/S4 & 5
Approval Date: 4/17/01

• 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)  

• Chemistry 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: October 26, 2001

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