Drug Approval Package
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FENTORA (fentanyl) Buccal Tablet
Company: Cephalon, Inc.
Application No.: 021947
Approval Date: 9/25/2006
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Approval Letter(s) (PDF)
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Approvable Letter (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
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Chemistry Review(s) (PDF)
- Clinical Pharmacology and Biopharmaceutics Review (PDF)
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Pharmacology Review(s) (PDF)
- Statistical Review (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: December 6, 2007
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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