Drug Approval Package

Nexium (Esomeprazole Magnesium) Delayed-Release Capsules
Company:  AstraZeneca LP
Application No.:  21-153 & 21-154
Approval Date: 2/20/2001

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s)

  Part 1 (PDF)	Part 6 (PDF)
  Part 2 (PDF)	Part 7 (PDF)
  Part 3 (PDF)	Part 8 (PDF)
  Part 4 (PDF)	Part 9 (PDF)
  Part 5 (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

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

• Administrative Document(s) (PDF)  

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

Date created: September 07, 2001

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