Drug Approval Package

Atacand HCT (Candesartan Cilexetil-Hydrochlorothiazide) Tablets
Company:  AstraZeneca LP
Application No.:  21-093
Approval Date: 9/5/2000

• Approval Letter(s)(PDF)  

• Printed Labeling(PDF)  

• Medical Review(s)

  Part 1(PDF)
  Part 2(PDF)

• Chemistry Review(s)(PDF)  

• Environmental Assessment(PDF)  

• Pharmacology Review(s)

  Part 1(PDF)
  Part 2(PDF)

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

• Clinical Pharmacology Biopharmaceutics Review(s)(PDF)  

• Administrative Document(s)(PDF)  

• Correspondence(PDF)  

Date created: July 30,2001

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