Drug Approval Package
Eovist (Gadoxetate Disodium) Injection
Company: Bayer Healthcare Pharmaceuticals
Application No.: 022090
Approval Date: 07/03/2008
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
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Summary Review (PDF)
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Officer/Employee List (PDF)
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Office Director Memo (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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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
Approval Letter(s) (PDF)
Date created: August 19, 2008
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