Drug Approval Package

NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection [rDNA origin]
Company:  Novo Nordisk Inc.
Application No.:  021810
Approval Date: 8/26/2008

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• Approval Letter(s) (PDF)
• Approvable Letter (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Microbiology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Administrative Document(s) & Correspondence
  • Part 1 (PDF)
  • Part 2 (PDF)

Date created: August 13, 2009

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