Drug Approval Package
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Romiplostim
Company: Amgen, Inc.
NDA: 125268
Approval Date: 8/22/2008
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)
- Office Director Memo(PDF)
- Cross Discipline Team Leader Review(PDF)
- Medical Review(s)
- 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) and Correspondence (PDF)
Date created: October 17, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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