Drug Approval Package
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Sporanox (itraconazole)
injection 10mg/ml
Company: Janssen Research Foundation
Application No.: 020996
Approval Date: 3/30/1999
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Correspondence (PDF)
Date created: August 13, 2003
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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