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) 019090
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
Labels are not available on this site for ZANTAC, (NDA) 019090
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
7/12/2006 050Labeling Revision Letter 
3/14/2002 047Package Change  
1/15/2002 046Control Supplement  
1/7/2002 045Labeling Revision Letter 
5/9/2001 044Labeling Revision  
10/29/1999 043Labeling Revision  
4/2/1999 042Manufacturing Change or Addition  
11/6/2001 041Manufacturing Change or Addition  
10/22/1999 040Labeling Revision  
10/22/1999 039Labeling Revision  
1/14/1998 038Control Supplement  
10/29/1999 037Labeling Revision Letter
Review 
11/3/1994 035Labeling Revision  
4/5/1993 032Labeling Revision  
7/22/1992 031Control Supplement  
9/5/1991 030Labeling Revision  
12/20/1990 029Manufacturing Change or Addition  
5/19/1992 028Package Change  
11/21/1990 027Labeling Revision  
12/12/1990 026Manufacturing Change or Addition  
7/16/1990 025Labeling Revision  
11/25/1991 024Labeling Revision  
6/25/1990 021Control Supplement  
5/18/1989 020Labeling Revision  
8/8/1989 019Manufacturing Change or Addition  
9/26/1990 018Package Change  
8/13/1990 017New Dosage Regimen  
3/17/1989 016Labeling Revision  
5/20/1988 015Labeling Revision  
5/20/1988 014Labeling Revision  
3/17/1989 013Labeling Revision  
5/19/1988 012Labeling Revision  
11/24/1987 011Manufacturing Change or Addition  
4/9/1987 009Labeling Revision  
3/3/1988 008Package Change  
8/8/1986 006Control Supplement  
4/9/1987 005Manufacturing Change or Addition  
4/9/1987 004Package Change  
2/28/1986 003Manufacturing Change or Addition  
8/8/1985 002Package Change  
4/16/1985 001Manufacturing Change or Addition  
10/19/1984 000Approval  
 
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