Drug Approval Package

Thyrogen (Thyrotropin Alfa) Injection
Company:  Genzyme Corporation
Application No.:  20-898
Approval Date: 11/30/1998

• 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)
  Part 6 (PDF)
  Part 7 (PDF)

• Chemistry Review(s) (PDF)  

• Environmental Assessment (PDF)  

• Pharmacology Review(s) (PDF)  

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

• Microbiology Review(s) (PDF)   

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  
  Part 5 (PDF)  
  Part 6 (PDF)  
  Part 7 (PDF)  

Date created: September 10, 2001

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