Visitor Monitoring Drug History: ZANTAC IN PLASTIC CONTAINER
 
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Label and Approval History

Drug Name: ZANTAC IN PLASTIC CONTAINER
FDA Application No: (NDA) 019593
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on October 29, 1999 for ZANTAC IN PLASTIC CONTAINER, (NDA) 019593


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 038Labeling Revision Letter 
12/13/2001 035Manufacturing Change or Addition  
1/15/2002 034Control Supplement  
1/7/2002 033Labeling Revision Letter 
5/9/2001 032Labeling Revision  
10/29/1999 031Labeling Revision  
10/22/1999 030Labeling Revision  
10/22/1999 029Labeling Revision  
10/29/1999 028Labeling Revision Letter
Label
Review 
11/3/1994 026Labeling Revision  
8/10/1994 025Labeling Revision  
8/12/1992 023Control Supplement  
4/5/1993 021Labeling Revision  
7/22/1992 020Control Supplement  
2/18/1992 019Package Change  
9/5/1991 018Labeling Revision  
12/20/1990 017Manufacturing Change or Addition  
11/21/1990 016Labeling Revision  
1/17/1991 015Control Supplement  
12/12/1990 014Manufacturing Change or Addition  
7/16/1990 013Labeling Revision  
11/25/1991 012Labeling Revision  
8/13/1990 011Labeling Revision  
5/18/1989 010Labeling Revision  
8/8/1989 008Manufacturing Change or Addition  
5/20/1988 007Labeling Revision  
5/20/1988 006Labeling Revision  
3/17/1989 005Labeling Revision  
1/4/1988 004Labeling Revision  
5/18/1987 002Package Change  
12/17/1986 000Approval  
 
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