Drug Approval Package
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Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension
Company: Wyeth Pharmaceuticals, Inc.
NDA: 022020
Approval Date: 11/14/2007
- Approvable Letter(s) (PDF)
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
Date created: March 31, 2009
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