Visitor Monitoring Drug History: ZANTAC 300
 
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Label and Approval History

Drug Name: ZANTAC 300
FDA Application No: (NDA) 020095
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
Labels are not available on this site for ZANTAC 300, (NDA) 020095
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/15/2002 014Control Supplement  
1/7/2002 013Labeling Revision Letter 
5/9/2001 012Labeling Revision  
10/29/1999 011Labeling Revision  
10/22/1999 010Labeling Revision  
10/22/1999 009Labeling Revision  
9/12/1997 008Manufacturing Change or Addition  
10/29/1999 007Labeling Revision Letter
Review 
11/27/1996 006Labeling Revision Review 
3/29/1995 005Labeling Revision  
11/14/1994 004Labeling Revision  
11/3/1994 002Labeling Revision  
4/4/1994 001Labeling Revision  
3/8/1994 000Approval  
 
Therapeutic Equivalents
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