Drug Approval Package

 Prilosec (Omeprazole Magnesium) Delayed-Release Tablets
Company:  Proctor and Gambel Co.
Application No.:  021229
Approval Date: 6/20/2003

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: April 082005

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