Drug Approval Package

Omtryg capsules 1.2 grams (omega-3-acid ethyl esters A capsules, 1.2 grams)
Company:  Beckloff Associates, Inc.
Application No.:  204977
Approval Date: 4/23/2014

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• Approval Letter(s) (PDF)
• Printed Labeling (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Microbiology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: December 18, 2014

Updated: June 27, 2016

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