Drug Approval Package

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Drug Approval Package

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Compath (Alemtuzumab) Intravenous
Company: Ilex Pharmaceuticals
Application No.: 103948
Approval Date: 6/23/2000

Approvable Letter(s)
Part 1 (PDF)
Part 2 (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Environmental Assessment (PDF)
Pharmacology Review(s) (PDF)
Statistical Review(s) (PDF)
Microbiology Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)

Date created: September 132005

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