Drug Approval Package
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Onsolis (fentanyl buccal soluble film) 200, 400, 800, and 1200 mcg
Company: BioDelivery Sciences International, Inc.
Application No.: 022266
Approval Date: 7/16/2009
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Summary Review
- Officer/Employee List (PDF)
- Printed Labeling (PDF)
- Medical Review(s)
- Chemistry Review(s)
- Pharmacology Review(s)
- Statistical Review(s)
- Clinical Pharmacology Biopharmaceutics Review(s)
- Risk Evaluation and Mitigation Strategy
- Risk Assessment and Risk Mitigation Review(s)
- Proprietary Name Review(s)
- Other Action Letter(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence
Date created: November 5, 2009
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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