Drug Approval Package
Uloric (Febuxostat) Tablets
Company: Takeda Pharmaceuticals Inc.
Application No.: 021856
Approval Date: 2/13/2009
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
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Approval Letter(s) (PDF)
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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)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF)
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Chemistry Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF) -
Other Review(s) (PDF)
- Administrative
Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Date created: April 07, 2009
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