Drug Approval Package

 Topamax (Topiramate) Tablets & Sprinkle Capsules
Company:  R.W. Johnson Pharmaceutical Research Institute
Application No.:  020505s002 & 20-844s010
Approval Date: 8/28/2001

• Approval Letter(s) (PDF)    

• Printed Labeling (PDF)    

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Statistical Review(s) (PDF)    

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

Date created: October 26, 2004

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