Drug Approval Package
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OptiMark (Gadoversetamide)
Injection
Company: Tyco/Mallinckrodt Health Care
Application No.: 020937/S003, 020975/S003 & 20976/S003
Approval Date: 1/31/2003
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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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Pharmacology Review(s) (PDF)
Date created: January /29/2004
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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