Drug Approval Package
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Omacor
(Omega-3-Acid Ethyl Esters) Capsules
Company: Abbott Laboratories
Application No.: 021654
Approval Date: 11/10/2004
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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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Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Date created: January 052005
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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