Drug Approval Package

Calomist (cyanocobalamin, USP) Nasal Spray, 25 mcg/0.1 mL
Company: Fleming & Co., Pharmaceuticals
NDA: 022102
Approval Date: 7/27/2007

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

• Approval Letter(s) (PDF)
  
  
• Printed Labeling (PDF)
  
  
• Summary Review (PDF)
  
  
• Medical Review(s) (PDF) 
  
  
• Chemistry Review(s) (PDF)
  
  
• Environmental Assessment (PDF)
  
  
• Pharmacology Review(s) (PDF)
  
  
• Microbiology Review(s) (PDF)  
  
  
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  
  
  
• Proprietary Name Review(s) (PDF)
  
  
• Other Review(s) (PDF)

• Administrative Document(s) and Correspondence (PDF)

Date created: April 14, 2009

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