Drug Approval Package
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Omniscan (Gadodiamide) Injection
Company: GE HealthCare
Application No.: 022066
Approval Date: 09/05/2007
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Approval Letter(s) (PDF)
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Approvable Letter (PDF)
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Summary Review (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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Environmental Assessment (PDF)
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Microbiology Review(s) (PDF)
Date created: October 3, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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