Drug Approval Package

 Zegerid (Omeprazole) Powder, Oral Suspension
Company:  Santarus, Inc.
Application No.:  021636
Approval Date: 6/15/2004

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: December 062005

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