Drug Approval Package
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Cimzia (Certolizumab Pegol) Injection
Company: UCB Inc.
Application No.: 125160
Approval Date: 04/22/2008
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Printed Labeling (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Office Director Memo (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Statistical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Administrative Document(s) & Correspondence(PDF)
Approval Letter(s) (PDF)
Date created: July 7, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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