Drug Approval Package

 Norvase (Amlodipine Besylate) Tablets
Company: Pfizer Inc.
Application No.:  019787s030
Approval Date: 01/08/2004

• Approval Letter(s) (PDF)  

• Approvable Letter(s) (PDF)  

• Medical Review(s) (PDF)

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: February 282007

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.