Visitor Monitoring Drug History: ZANTAC 25
 
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Label and Approval History

Drug Name: ZANTAC 25
FDA Application No: (NDA) 020251
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on May 2, 2005 for ZANTAC 25, (NDA) 020251


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
7/12/2006 017Labeling Revision Letter 
4/28/2005 016Labeling Revision Letter
Label 
4/1/2004 015Formulation Revision Letter
Label 
1/15/2002 012Control Supplement  
1/7/2002 011Labeling Revision Letter 
5/9/2001 010Labeling Revision  
10/29/1999 009Labeling Revision  
10/22/1999 008Labeling Revision  
10/22/1999 007Labeling Revision  
10/29/1999 006Labeling Revision Letter
Review 
11/27/1996 005Labeling Revision  
3/29/1995 004Labeling Revision  
11/14/1994 003Labeling Revision  
11/3/1994 001Labeling Revision  
3/31/1994 000Approval  
 
There are no Therapeutic Equivalents
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