Drug Approval Package
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Omeprazole 20 mg Delayed-Release Tablets
Company: Dexcel Pharma Technologies Ltd.
Application No.: 022032
Approval Date: 12/4/2007
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Approvable Letter (PDF)
- Tentative Approval Letter(s) (PDF)
- Summary Review (PDF)
- Printed Labeling (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
Date created: May 28, 2009
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
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