APPLICATION
NDA017560
TYPE
NDA
ORIGINAL APPROVAL
1975-04-15
LATEST ACTION
2025-02-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
BACTRIM · ReferenceDiscontinued
SULFAMETHOXAZOLE 200MG/5ML, TRIMETHOPRIM 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL
BACTRIM PEDIATRICDiscontinued
SULFAMETHOXAZOLE 200MG/5ML, TRIMETHOPRIM 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL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
2001-11-09Manufacturing (CMC) · Supplement 43 · standardAP
1996-03-06Labeling · Supplement 35AP
1990-06-15Efficacy · Supplement 39AP
1987-08-11Labeling · Supplement 34AP
1987-06-04Manufacturing (CMC) · Supplement 36 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 33 · standardAP
1985-02-20Manufacturing (CMC) · Supplement 32 · standardAP
1984-11-23Labeling · Supplement 30AP
1984-06-12Manufacturing (CMC) · Supplement 31 · standardAP
1982-06-15Manufacturing (CMC) · Supplement 28 · standardAP
1982-03-29Manufacturing (CMC) · Supplement 27 · standardAP
1982-02-23Efficacy · Supplement 18AP
1981-10-09Manufacturing (CMC) · Supplement 26 · standardAP
1981-04-23Manufacturing (CMC) · Supplement 25 · standardAP
1981-01-09Manufacturing (CMC) · Supplement 23 · standardAP
1981-01-09Manufacturing (CMC) · Supplement 24 · standardAP
1981-01-09Manufacturing (CMC) · Supplement 22 · standardAP
1980-12-10Manufacturing (CMC) · Supplement 20 · standardAP
1980-10-31Labeling · Supplement 19AP
1980-10-28Manufacturing (CMC) · Supplement 21 · standardAP
1979-12-17Manufacturing (CMC) · Supplement 17 · standardAP
1979-12-17Labeling · Supplement 16AP
1979-12-17Labeling · Supplement 14AP
1979-12-07Manufacturing (CMC) · Supplement 15 · standardAP
1979-12-07Manufacturing (CMC) · Supplement 13 · standardAP
1979-07-26Labeling · Supplement 12AP
1979-02-27Manufacturing (CMC) · Supplement 11 · standardAP
1978-10-11Labeling · Supplement 8AP
1978-03-01Labeling · Supplement 7AP
1977-11-14Labeling · Supplement 10AP
1977-04-21Manufacturing (CMC) · Supplement 9 · standardAP
1976-12-27Manufacturing (CMC) · Supplement 5 · standardAP
1976-08-23Manufacturing (CMC) · Supplement 6 · standardAP
1976-06-01Labeling · Supplement 3AP
1975-04-15Type 3 - New Dosage Form · 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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