Drug Approval Package

 Mycamine (micafungin sodium) Injection
Company: Fujisawa, Inc.
Application Number: 021754
Approval Date: 3/16/2005

• Approval Letter(s) (PDF)    

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  
  Part 5 (PDF)  
  Part 6 (PDF)  
  Part 7 (PDF)  
  Part 8 (PDF)  
  Part 9 (PDF)  

• Chemistry Review(s) (PDF)    

• Microbiology Review
• Clinical Pharmacology Review
• Pharmacology Review

• Statistical Review(s) (PDF)      

• Administrative Document(s) & Correspondence (PDF)  

Date created: December 6, 2007
Updated: February 29, 2012

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