APPLICATION
NDA018452
TYPE
NDA
ORIGINAL APPROVAL
1981-06-23
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SEPTRADiscontinued
SULFAMETHOXAZOLE 80MG/ML, TRIMETHOPRIM 16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2009-03-13Efficacy · Supplement 3AP
2009-03-13Labeling · Supplement 11AP
1997-03-19Labeling · Supplement 16AP
1997-03-19Labeling · Supplement 22 · standardAP
1997-03-19Labeling · Supplement 12AP
1997-03-19Labeling · Supplement 13AP
1997-02-14Labeling · Supplement 24 · standardAP
1996-09-11Labeling · Supplement 21 · standardAP
1996-07-12Manufacturing (CMC) · Supplement 23 · standardAP
1993-03-16Manufacturing (CMC) · Supplement 20 · standardAP
1993-02-22Manufacturing (CMC) · Supplement 19 · standardAP
1992-12-01Manufacturing (CMC) · Supplement 17 · standardAP
1992-08-21Labeling · Supplement 18AP
1990-11-09Labeling · Supplement 8AP
1990-07-09Manufacturing (CMC) · Supplement 15 · standardAP
1989-04-06Manufacturing (CMC) · Supplement 14 · standardAP
1987-11-02Manufacturing (CMC) · Supplement 10 · standardAP
1987-08-11Labeling · Supplement 7AP
1987-04-22Manufacturing (CMC) · Supplement 9 · standardAP
1986-03-14Manufacturing (CMC) · Supplement 6 · standardAP
1984-11-01Labeling · Supplement 2AP
1984-06-01Labeling · Supplement 5AP
1983-05-16Manufacturing (CMC) · Supplement 4 · standardAP
1982-09-16Manufacturing (CMC) · Supplement 1 · standardAP
1981-06-23Type 5 - New Formulation or New Manufacturer · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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