Drug Approval Package

Infasurf (calfactant) Intratracheal Suspension
Company:  ONY, Inc.
Application No.:  20-521
Approval Date: 7/1/1998

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

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

• Chemistry Review(s) (PDF)  

• Environmental Assessment (PDF)  

• Pharmacology Review(s) (PDF)  

• Microbiology Review(s) (PDF)   

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence
  Part 1 (PDF)  
  Part 2 (PDF)  

Date created: April 04, 2002

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