Drug Approval Package

Cyanokit (hydroxocobalamin for injection) 5 g for intravenous use
Company: EMD Pharmaceuticals, Inc.
NDA: 022041
Approval Date: 12/15/2006

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)
• Medical Review(s)
  • Part 1 (PDF)  
  • Part 2 (PDF) 
• Chemistry Review(s) (PDF)
• Pharmacology Review(s)
  
  • Part 1 (PDF)  
  • Part 2 (PDF)  
  • Part 3 (PDF)   
• Statistical Review(s) (PDF)
• Microbiology Review(s) (PDF)  
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  
• Administrative Document(s) and Correspondence (PDF)
  

Date created: December 12, 2008

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.