Drug Approval Package
Arixtra
(Fondaparinux Sodium) Injection
Company: Fonda BV
Application No.: 21-345
Approval Date: 12/7/2001
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review
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Addendum to Medical Officer's Safety Review (PDF) (7/22/2003)
Part 1 (PDF) Part 4 (PDF) Part 7 (PDF) Part 2 (PDF) Part 5 (PDF) Part 8 (PDF) Part 3 (PDF) Part 6 (PDF) Part 9 (PDF) -
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Chemistry Review(s) (PDF)
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Pharmacology Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF) -
Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Correspondence (PDF)
Date created: July 22, 2003
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