Drug Approval Package

Tapentadol Hydrochloride Tablets
Company: Ortho McNeil Janssen
Application No.:  022304
Approval Date: 12/24/2008

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

Approval Letter(s) (PDF) 

• Summary Review (PDF) 

• Officer/Employee List (PDF) 

• Cross Disipline Team Leader Review (PDF) 

• Printed Labeling (PDF) 

• Medical Review(s)

  • Part 1 (PDF) 
  • Part 2 (PDF) 

• Chemistry Review(s) (PDF) 

• Environmental Assessment (PDF) 

• Pharmacology Review(s)

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

• Statistical Review(s) (PDF) 

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 

• Risk Assessment and Risk Mitigation Review(s) (PDF) 

• Other Review(s) (PDF) 

• Administrative Document(s) & Correspondence (PDF) 

Date created: January 26, 2009

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