Drug Approval Package
Drug Review Package
Fuzeon (enfuvirtide) for injection
Company: Hoffman-LaRoche, Inc.
Application No.: 021481
Approval Date: 3/13/2003
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF) -
Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF) -
Administrative Document(s) & Correspondence (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Date created: July 23, 2003
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