Drug Approval Package

Budesonide inhalation powder
Company: AstraZeneca Pharmaceuticals
NDA: 021949
Approval Date: 7/12/2006

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

Date created: November 17, 2008

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