Drug Approval Package

Exforge (amlodipine and valsartan) 5/160, 10/160, 5/320, and mg Tablets
Company: Novartis Pharmaceuticals Corporation
NDA: 021990
Approval Date: 6/20/2007

• Tenative Approval Letter(s) (PDF)
• 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)
• Proprietary Name Review(s) (PDF)
• Administrative Document(s) and Correspondence (PDF)

Date created: October 3, 2008

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