Drug Approval Package

 Omacor (Omega-3-Acid Ethyl Esters) Capsules
Company:  Abbott Laboratories
Application No.:  021654
Approval Date: 11/10/2004

• Approval Letter(s) (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)

• Administrative Document(s) & Correspondence
  Part 1 (PDF)  
  Part 2 (PDF)  

Date created: January 052005

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