Visitor Monitoring Drug History: BACTRIM DS
 
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: BACTRIM DS
FDA Application No: (NDA) 017377
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
Company: MUTUAL PHARM
 
Label History
 
View the label approved on June 7, 2007 for BACTRIM DS, (NDA) 017377


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
6/5/2007 063Labeling Revision Letter
Label 
10/17/2002 058Formulation Revision Letter
Label 
2/12/2003 057Labeling Revision Letter
Label 
11/17/1998 056Labeling Revision  
4/18/1994 055Package Change  
7/3/2000 053Labeling Revision  
7/17/1990 052Manufacturing Change or Addition  
7/3/2000 050Labeling Revision  
5/11/1987 049Control Supplement  
5/11/1987 048Control Supplement  
3/6/1996 047Labeling Revision  
8/11/1987 046Labeling Revision  
3/19/1985 045Package Change  
6/12/1984 044Control Supplement  
11/23/1984 043Labeling Revision  
5/9/1984 042Package Change  
8/1/1983 041Manufacturing Change or Addition  
6/15/1990 040New or Modified Indication  
6/15/1983 039Control Supplement  
10/9/1981 037Control Supplement  
12/9/1981 036Labeling Revision  
4/23/1981 035Control Supplement  
4/1/1981 034Control Supplement  
10/31/1980 033Labeling Revision  
2/23/1982 032General Efficacy (MarkIV)  
3/6/1980 031Control Supplement  
12/17/1979 030Labeling Revision  
4/18/1979 029Control Supplement  
4/19/1978 028Control Supplement  
10/11/1978 027Labeling Revision  
4/18/1978 026Labeling Revision  
3/1/1978 025Labeling Revision  
1/12/1978 024Control Supplement  
7/26/1979 023Labeling Revision  
5/2/1977 022Labeling Revision  
1/19/1977 021Labeling Revision  
11/22/1976 020Control Supplement  
10/1/1976 019Control Supplement  
2/15/1977 018Control Supplement  
5/12/1976 016Formulation Revision  
2/12/1976 013Control Supplement  
7/3/1975 012Control Supplement  
4/14/1975 011Control Supplement  
12/5/1974 010Labeling Revision  
12/5/1974 009Labeling Revision  
1/22/1975 006Control Supplement  
6/12/1974 004Supplement  
7/30/1973 000Approval  
 
There are no Therapeutic Equivalents
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