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Drug Review Package
Fuzeon (enfuvirtide) for injection
Company:  Hoffman-LaRoche, Inc.
Application No.:  021481
Approval Date: 3/13/2003
Approval Letter(s) (PDF)   
Printed Labeling (PDF)     
Medical Review(s) (PDF)   
Chemistry Review(s) (PDF)   
Clinical Review
Part 1
Part 2
Part 3
Pharmacology Review(s) (PDF)  
Part 1 (PDF)  
Part 2 (PDF)  
Part 3 (PDF)  
Part 4 (PDF)   
Statistical Review(s) (PDF)   
Microbiology Review(s) (PDF)   
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  
Part 1 (PDF)  
Part 2 (PDF)  
Part 3 (PDF)   
Administrative Document(s) & Correspondence (PDF)  
Part 1 (PDF)  
Part 2 (PDF)  
Part 3 (PDF)

Date created: July 23, 2003
Back to Top    Drugs@FDA7
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