Drug Approval Package
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OptiMark
(Gadoversetamide) Injection
Company: Mallinckrodt, Inc.
Application No.: 20-937, 20-975, & 20-976
Approval Date: 12/8/1999
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
Part 1 (PDF) Part 2 (PDF) Part 3 (PDF) Part 4 (PDF) Part 5 (PDF) Part 6 (PDF) -
Chemistry Review(s) (PDF)
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Environmental Assessment (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: March 30, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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