Visitor Monitoring Drug History: TAGAMET
 
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: TAGAMET
FDA Application No: (NDA) 017939
Active Ingredient(s): CIMETIDINE HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
Labels are not available on this site for TAGAMET, (NDA) 017939
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/15/1997 086Control Supplement  
2/22/1995 085Labeling Revision  
11/10/1993 084Manufacturing Change or Addition  
6/8/1993 083Manufacturing Change or Addition  
7/16/1992 081Control Supplement  
1/7/1992 080Labeling Revision  
8/27/1992 079Control Supplement  
11/13/1991 077New or Modified Indication  
3/21/1990 076Package Change  
5/30/1990 074Control Supplement  
3/7/1991 073Labeling Revision  
6/26/1989 072Labeling Revision  
3/20/1989 071Manufacturing Change or Addition  
6/26/1989 070Labeling Revision  
6/15/1988 068Labeling Revision  
5/20/1988 067Labeling Revision  
11/13/1989 066New Dosage Regimen  
6/3/1987 065Manufacturing Change or Addition  
3/31/1988 064New Dosage Regimen  
7/24/1986 063Expiration Date Change  
4/23/1986 061Labeling Revision  
1/13/1986 059Labeling Revision  
5/15/1985 058Labeling Revision  
4/18/1985 057Labeling Revision  
2/7/1985 056Labeling Revision  
4/29/1986 055New Dosage Regimen  
1/23/1985 054Control Supplement  
6/18/1984 053Labeling Revision  
7/19/1984 052Labeling Revision  
7/11/1984 051Package Change  
3/5/1984 050Labeling Revision  
3/5/1984 049Labeling Revision  
11/29/1983 047Labeling Revision  
7/19/1984 045Labeling Revision  
2/28/1984 044Manufacturing Change or Addition  
2/28/1983 042Labeling Revision  
1/31/1983 041General Efficacy (MarkIV)  
4/22/1983 040Manufacturing Change or Addition  
11/20/1985 039New or Modified Indication  
8/25/1982 038General Efficacy (MarkIV)  
2/4/1982 036Labeling Revision  
1/22/1982 034Labeling Revision  
12/3/1981 033Expiration Date Change  
12/30/1982 032Labeling Revision  
11/2/1981 031Labeling Revision  
7/13/1981 030Labeling Revision  
1/22/1981 028Labeling Revision  
1/22/1981 027Labeling Revision  
12/30/1982 026General Efficacy (MarkIV)  
7/8/1980 025Labeling Revision  
7/8/1980 024Labeling Revision  
7/8/1980 023Labeling Revision  
2/11/1980 021Labeling Revision  
1/17/1980 020Control Supplement  
8/28/1981 019Expiration Date Change  
1/8/1980 018Control Supplement  
4/5/1979 017Labeling Revision  
3/16/1979 016Labeling Revision  
2/1/1979 015Labeling Revision  
12/4/1978 014Control Supplement  
11/30/1978 013Labeling Revision  
11/30/1978 012Labeling Revision  
12/4/1978 010Labeling Revision  
9/28/1978 009Labeling Revision  
9/28/1978 007Manufacturing Change or Addition  
3/16/1979 005Labeling Revision  
3/16/1979 004General Efficacy (MarkIV)  
12/27/1977 003Labeling Revision  
12/27/1977 001Labeling Revision  
8/16/1977 000Approval  
 
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