Visitor Monitoring Drug History: SEPTRA GRAPE
 
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: SEPTRA GRAPE
FDA Application No: (NDA) 017598
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
Company: MONARCH PHARMS
 
Label History
 
View the label approved on September 11, 2007 for SEPTRA GRAPE, (NDA) 017598


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
9/10/2007 041Labeling Revision Letter
Label 
7/28/2005 039Labeling Revision Letter
Label 
2/17/2000 038Manufacturing Change or Addition  
2/13/1997 037Labeling Revision  
3/19/1997 036Labeling Revision  
9/11/1996 033Labeling Revision  
1/7/1994 032Labeling Revision  
2/22/1993 031Manufacturing Change or Addition  
3/6/1991 030Control Supplement  
3/6/1991 029Control Supplement  
6/15/1990 028New or Modified Indication  
12/1/1992 027Control Supplement  
3/19/1997 026Labeling Revision  
8/8/1988 024Package Change  
3/19/1997 023Labeling Revision  
9/9/1988 022Labeling Revision  
11/9/1990 021Labeling Revision  
2/12/1986 020Formulation Revision  
8/11/1987 019Labeling Revision  
12/11/1984 018Formulation Revision  
11/1/1984 017Practioner Draft Labeling  
4/27/1982 016Labeling Revision  
3/22/1982 015Package Change  
7/16/1981 014Package Change  
1/13/1981 013Package Change  
10/31/1980 012Labeling Revision  
12/18/1979 011Control Supplement  
7/26/1979 010Labeling Revision  
8/26/1977 008Package Change  
10/11/1978 007General Efficacy (MarkIV)  
11/12/1976 006Formulation Revision  
3/1/1978 005General Efficacy (MarkIV)  
12/27/1976 004Labeling Revision  
6/1/1976 003Labeling Revision  
9/17/1975 002Control Supplement  
9/17/1975 001Labeling Revision  
5/31/1975 000Approval  
 
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