Drug Approval Package

 Accolate Tablets
Company:  Zeneca Pharmaceuticals
Application No.:  020547/S7
Approval Date: 9/17/1999

• 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) (PDF)    

• Correspondence (PDF)  

Date created: April 14, 2004

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