Drug Approval Package

Nutropin Depot (Somatropin [rDNA origin] Injection)
Company:  Genentech Inc.
Application No.:  21-075
Approval Date: 12/22/1999

• 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)  

• Statistical 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 20, 2001

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