Drug Approval Package

NitroMist (Nitroglycerin) Lingual Aerosol 400 mcg/actuation
Company: NovaDel Pharma Inc.
NDA: 021780
Approval Date: 11/2/2006

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

Date created: October 28, 2008

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