Drug Approval Package

Zegerid (Omeprazole/Sodium Bicarbonate) Capsules
Company: Santarus, Inc.
Application No.:  021849
Approval Date: 02/27/2006

• 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: May 7, 2008; updated May 28, 2008

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.