Drug Approval Package

Requip XL (ropinirole) Extended-Release Tablets 2, 3, 4, and 8 mg
Company: SmithKline Beecham
NDA: 022008
Approval Date: 6/13/2008

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Approvable Letter(s)(PDF)
• Approval Letter(s)(PDF)
• Printed Labeling(PDF)
• Officer/Employee List  (PDF)
• Medical Review(s)
  • Part 1(PDF)  
  • Part 2(PDF)  
  • Part 3(PDF) 
• Chemistry Review(s)(PDF)
• Statistical Review(s)(PDF)
• Clinical Pharmacology Biopharmaceutics Review(s)
  • Part 1(PDF)  
  • Part 2(PDF)  
• Risk Assessment and Risk Mitigation Review(s)(PDF)
• Administrative Document(s) and Correspondence(PDF)

Date created: December 29, 2008

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