Drug Approval Package

Treximet (sumatriptan and naproxen sodium) Tablets
Company: Pozen Inc.
Application No.:  021926
Approval Date: 04/15/2008

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Approval Letter(s) (PDF) 


• Approvable Letter (PDF) 

• Summary Review (PDF) 

• Officer/Employee List (PDF) 

• Printed Labeling (PDF) 

• Medical Review(s) 

  • Part 1 (PDF) 
  • Part 2 (PDF) 
  • Part 3 (PDF)
  • Part 4 (PDF) 
  • Part 5 (PDF)  

• Chemistry Review(s) (PDF) 

• Pharmacology Review(s) 

  • Part 1 (PDF) 
  • Part 2 (PDF) 
  • Part 3 (PDF)
  • Part 4 (PDF)  

• Statistical Review(s) (PDF) 

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 

• Proprietary Name Review(s) (PDF) 

• Administrative Document(s) & Correspondence (PDF) 

Date created: August 29, 2008

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