Drug Approval Package

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• 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) (PDF)  
• Correspondence (PDF)

Date created: November 20, 2001

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