Drug Approval Package

 Zantac 75 EFFERdose (Ranitidine Hydrochloride) Effervescent Tablets
Company:  Glaxo Wellcome Inc.
Application No.:  020745
Approval Date: 2/26/1998

• Approval Letter(s) (PDF)    

• Printed Labeling (PDF)    

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)    

• Environmental Assessment (PDF)

• Statistical Review(s) (PDF)    

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)    

• Administrative Document(s) & Correspondence (PDF)  

Date created: May 17, 2005

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