Drug Approval Package
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Omacor (omega-3-acid ethyl esters) Capsules, 1 gram
Company: Reliant Pharmaceuticals, Inc.
Application No.: 021853 & 021654s016
Approval Date: 6/12/2007
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Office Director Memo (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Statistical Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Other Action Letter(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: November 19, 2009
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