Drug Approval Package

Simponi (Golimumab) Injection
Company:  Centocor Ortho Biotech Inc.
Application No.:  125289
Approval Date: 4/24/2009

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)
• Office Director Memo (PDF)
• Cross Discipline Team Leader Review (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
  • Part 1 (PDF)
  • Part 2 (PDF)
  • Part 3 (PDF)
  • Part 4 (PDF)
  • Part 5 (PDF)
  • Part 6 (PDF)
  • Part 7 (PDF)
  • Part 8 (PDF
  • Part 9 (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
  • Part 1 (PDF)
  • Part 2 (PDF)
• Statistical Review(s) (PDF)
  • Part 1 (PDF)
  • Part 2 (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
  • Part 1 (PDF)
  • Part 2 (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: June 5, 2009

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