Drug History: SEPTRA

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	SEPTRA
FDA Application No:	(NDA) 017376
Active Ingredient(s):	SULFAMETHOXAZOLE; TRIMETHOPRIM
Company:	MONARCH PHARMS

Label History

View the label approved on September 11, 2007 for SEPTRA, (NDA) 017376

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 Date	Supplement Number	Approval Type	Letters, Reviews, Labels, Patient Package Insert
9/10/2007	059	Labeling Revision	Letter Label
7/28/2005	056	Labeling Revision	Letter Label
10/4/2000	055	Package Change
1/31/2000	054	Manufacturing Change or Addition
2/12/1997	053	Labeling Revision
4/7/1998	052	Labeling Revision
3/19/1997	051	Labeling Revision
9/11/1996	048	Labeling Revision
1/7/1994	047	Labeling Revision
2/22/1993	046	Manufacturing Change or Addition
12/1/1992	045	Control Supplement
3/19/1997	044	Labeling Revision
3/19/1997	042	Labeling Revision
6/15/1990	041	New or Modified Indication
2/2/1989	040	Labeling Revision
11/9/1990	039	Labeling Revision
8/9/1985	038	Control Supplement
8/11/1987	037	Labeling Revision
1/16/1985	036	Manufacturing Change or Addition
2/20/1985	035	Manufacturing Change or Addition
3/25/1983	033	Package Change
12/7/1982	032	Package Change
11/1/1984	031	Practioner Draft Labeling
4/27/1982	030	Labeling Revision
11/3/1981	029	Control Supplement
10/9/1981	028	Package Change
1/9/1981	027	Package Change
10/31/1980	026	Labeling Revision
9/9/1980	025	Expiration Date Change
10/28/1980	024	Control Supplement
11/20/1978	023	Package Change
12/8/1978	022	Control Supplement
7/26/1979	021	General Efficacy (MarkIV)
7/5/1977	020	Package Change
4/21/1977	019	Package Change
10/11/1978	017	General Efficacy (MarkIV)
11/22/1976	016	Package Change
11/22/1976	015	Package Change
3/7/1977	013	Formulation Revision
12/27/1976	012	Labeling Revision
2/12/1976	010	Labeling Revision
11/25/1974	008	Control Supplement
5/15/1975	006	Control Supplement
10/8/1974	005	Labeling Revision
5/1/1974	003	Supplement
10/8/1974	002	Supplement
7/30/1973	000	Approval

There are no Therapeutic Equivalents