Drug Approval Package: Omeprazole delayed-release orally disintegrating tablet
Company: Dexcel Pharma Technologies Ltd.
Application Number: 209400
Approval Date: 07/05/2017
Application Number: 209400
Approval Date: 07/05/2017
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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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