Drug Approval Package: Omeprazole delayed-release orally disintegrating tablet

Company: Dexcel Pharma Technologies Ltd.
Application Number: 209400
Approval Date: 07/05/2017

Drugs@FDA information available about Omeprazole

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FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• 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)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: March 21, 2018

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