Visitor Monitoring Drug History: ZANTAC
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: ZANTAC
FDA Application No: (NDA) 019675
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on May 2, 2005 for ZANTAC, (NDA) 019675


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 032Labeling Revision Letter 
4/28/2005 031Labeling Revision Letter
Label 
4/30/2004 030Control Supplement Letter 
9/24/2002 027Manufacturing Change or Addition  
1/15/2002 026Control Supplement  
1/7/2002 025Labeling Revision Letter 
5/9/2001 024Labeling Revision  
10/29/1999 023Labeling Revision  
10/22/1999 022Labeling Revision  
10/22/1999 021Labeling Revision  
10/29/1999 020Labeling Revision Letter
Review 
11/27/1996 019Labeling Revision  
11/3/1994 017Labeling Revision  
3/29/1995 016New or Modified Indication  
1/30/1995 015Package Change  
4/5/1993 014Labeling Revision  
11/3/1994 013Labeling Revision  
2/28/1994 012Labeling Revision  
7/22/1992 011Control Supplement  
5/19/1992 009Labeling Revision  
12/20/1990 008Manufacturing Change or Addition  
11/21/1990 007Labeling Revision  
12/12/1990 006Manufacturing Change or Addition  
7/16/1990 004Labeling Revision  
11/25/1991 003Labeling Revision  
5/18/1989 002Labeling Revision  
8/8/1989 001Manufacturing Change or Addition  
12/30/1988 000Approval Review 
 
Therapeutic Equivalents
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