Drug Approval Package

NovoLog (Insulin Aspart [rDNA origin] Injection)
Company:  Novo Nordisk Pharmaceuticals Inc.
Application No.:  20-986
Approval Date: 6/7/2000

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

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

• Chemistry Review(s) (PDF)  

• Environmental Assessment (PDF)  

• Pharmacology Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  
  Part 5 (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 30, 2002

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