Drug Approval Package
Xenazine (Tetrabenazine) Tablets
Company: Prestwick Pharmaceuticals Inc.
Application No.: 021894
Approval Date: 08/15/2008
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
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Approvable Letter (PDF)
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Summary Review (PDF)
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Officer/Employee List (PDF)
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Office Director Memo (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s)
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Statistical Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Approval Letter(s) (PDF)
Date created: October 9, 2008
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