APPLICATION
NDA017598
TYPE
NDA
ORIGINAL APPROVAL
1975-05-31
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
SEPTRADiscontinued
SULFAMETHOXAZOLE 200MG/5ML, TRIMETHOPRIM 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL
SEPTRA GRAPEDiscontinued
SULFAMETHOXAZOLE 200MG/5ML, TRIMETHOPRIM 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL
Approval history
2009-03-13Labeling · Supplement 9AP
2000-02-17Manufacturing (CMC) · Supplement 38 · standardAP
1997-03-19Labeling · Supplement 36 · standardAP
1997-03-19Labeling · Supplement 26AP
1997-03-19Labeling · Supplement 23AP
1997-02-13Labeling · Supplement 37 · standardAP
1996-09-11Labeling · Supplement 33 · standardAP
1994-01-07Labeling · Supplement 32 · standardAP
1993-02-22Manufacturing (CMC) · Supplement 31 · standardAP
1992-12-01Manufacturing (CMC) · Supplement 27 · standardAP
1991-03-06Manufacturing (CMC) · Supplement 30 · standardAP
1991-03-06Manufacturing (CMC) · Supplement 29 · standardAP
1990-11-09Labeling · Supplement 21AP
1990-06-15Efficacy · Supplement 28AP
1988-09-09Labeling · Supplement 22AP
1988-08-08Manufacturing (CMC) · Supplement 24 · standardAP
1987-08-11Labeling · Supplement 19AP
1986-02-12Manufacturing (CMC) · Supplement 20 · standardAP
1984-12-11Manufacturing (CMC) · Supplement 18 · standardAP
1984-11-01Labeling · Supplement 17AP
1982-04-27Labeling · Supplement 16AP
1982-03-22Manufacturing (CMC) · Supplement 15 · standardAP
1981-07-16Manufacturing (CMC) · Supplement 14 · standardAP
1981-01-13Manufacturing (CMC) · Supplement 13 · standardAP
1980-10-31Labeling · Supplement 12AP
1979-12-18Manufacturing (CMC) · Supplement 11 · standardAP
1979-07-26Labeling · Supplement 10AP
1978-10-11Efficacy · Supplement 7AP
1978-03-01Efficacy · Supplement 5AP
1977-08-26Manufacturing (CMC) · Supplement 8 · standardAP
1976-12-27Labeling · Supplement 4AP
1976-11-12Manufacturing (CMC) · Supplement 6 · standardAP
1976-06-01Labeling · Supplement 3AP
1975-09-17Manufacturing (CMC) · Supplement 2 · standardAP
1975-09-17Labeling · Supplement 1AP
1975-05-31Type 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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