Drug Approval Package
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Zegerid OTC (Omeprazole & Sodium Bicarbonate) Capsules
Company: Schering-Plough Healthcare Products, Inc.
Application No.: 022281
Approval Date: 12/01/2009
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Office Director Memo (PDF
- Other Action Letters (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology 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: February23, 2010
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