Visitor Monitoring Drug History: ZANTAC 300
 
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Label and Approval History

Drug Name: ZANTAC 300
FDA Application No: (NDA) 018703
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on May 2, 2005 for ZANTAC 300, (NDA) 018703


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 066Labeling Revision Letter 
4/28/2005 065Labeling Revision Letter
Label 
1/15/2002 062Control Supplement  
1/7/2002 061Labeling Revision Letter 
5/9/2001 060Labeling Revision  
10/29/1999 059Labeling Revision  
10/22/1999 058Labeling Revision  
10/22/1999 057Labeling Revision  
10/29/1999 056Efficacy Supplement with Clinical Data to Support Letter
Review 
11/27/1996 055Labeling Revision  
11/3/1994 053Labeling Revision  
1/26/1996 052Manufacturing Change or Addition  
10/19/1994 051Manufacturing Change or Addition  
3/29/1995 050New or Modified Indication  
6/3/1993 049Package Change  
4/5/1993 048Labeling Revision  
11/3/1994 047New or Modified Indication  
2/28/1994 046New Dosage Regimen  
7/22/1992 045Control Supplement  
7/2/1992 044Package Change  
5/19/1992 042New or Modified Indication  
12/20/1990 041Manufacturing Change or Addition  
11/21/1990 040Labeling Revision  
12/12/1990 039Manufacturing Change or Addition  
7/16/1990 037Labeling Revision  
11/25/1991 036Labeling Revision  
1/4/1991 035Control Supplement  
1/4/1991 034Control Supplement  
5/18/1989 033Labeling Revision  
2/6/1990 032Manufacturing Change or Addition  
8/8/1989 031Manufacturing Change or Addition  
10/25/1988 030Labeling Revision  
2/3/1989 029Labeling Revision  
9/29/1988 028Control Supplement  
9/30/1988 027Control Supplement  
5/20/1988 026Labeling Revision  
5/20/1988 025Labeling Revision  
10/29/1987 024Labeling Revision  
8/27/1987 023Manufacturing Change or Addition  
4/24/1987 022Expiration Date Change  
3/6/1987 020Labeling Revision  
10/27/1986 019Package Change  
10/27/1986 018Control Supplement  
8/8/1986 017Control Supplement  
12/9/1985 016Labeling Revision  
2/20/1986 015Control Supplement  
11/20/1985 014Package Change  
8/23/1985 013Package Change  
12/9/1985 012Control Supplement  
2/22/1985 011Control Supplement  
2/4/1985 010Expiration Date Change  
5/30/1986 008New or Modified Indication  
9/13/1984 007Package Change  
12/9/1985 006New Dosage Regimen  
8/27/1984 005Labeling Revision  
5/30/1986 004New or Modified Indication  
2/28/1984 003Control Supplement  
6/28/1985 002General Efficacy (MarkIV)  
1/5/1984 001Manufacturing Change or Addition  
6/9/1983 000Approval  
 
Therapeutic Equivalents
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