Drug Approval Package

Dutoprol (Metoprolol Succinate) Extended Release Tablets
Company: AstraZeneca LP
Application No.:  021956
Approval Date: 08/28/2006

• Approval Letter(s) (PDF) 
  

• Printed Labeling (PDF) 

• Medical Review(s) (PDF) 

• Chemistry Review(s) (PDF) 

• Pharmacology Review(s) (PDF) 

• Statistical Review(s) (PDF) 

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 

• Administrative Document(s) & Correspondence (PDF) 

Date created: May 7, 2008

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