Drug Approval Package
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Busulfex (Busulfan) Injection
Company: Orphan Medical, Inc.
Application No.: 20-954/S5
Approval Date: 11/13/2002
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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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Microbiology Review(s) (PDF)
Date created: July 08, 2003
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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