Drug Approval Package

 Pulmicort Respules (Budesonide) Inhalation Suspension
Company:  AstraZeneca LP
Application No.:  020929
Approval Date: 8/9/2000

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  
  Part 5 (PDF)  
  Part 6 (PDF)  
  Part 7 (PDF)

• Chemistry Review(s) (PDF)

• Pharmacology Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  

• Statistical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)

• Correspondence
  Part 1 (PDF)  
  Part 2 (PDF)  

Date created  2/9/2004

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