APPLICATION
NDA018852
TYPE
NDA
ORIGINAL APPROVAL
1983-05-09
LATEST ACTION
2001-12-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIMDiscontinued
SULFAMETHOXAZOLE 400MG, TRIMETHOPRIM 80MG · TABLET · ORAL
Approval history
2001-12-12Labeling · Supplement 26AP
2001-06-27Manufacturing (CMC) · Supplement 24AP
2001-04-25Manufacturing (CMC) · Supplement 25AP
2000-07-31Manufacturing (CMC) · Supplement 23AP
1997-10-21Labeling · Supplement 21AP
1994-02-09Labeling · Supplement 20AP
1993-02-25Manufacturing (CMC) · Supplement 19AP
1991-08-07Manufacturing (CMC) · Supplement 17AP
1991-01-28Manufacturing (CMC) · Supplement 18AP
1990-06-29Manufacturing (CMC) · Supplement 16AP
1990-02-22Labeling · Supplement 15AP
1988-09-01Manufacturing (CMC) · Supplement 14AP
1988-04-11Labeling · Supplement 13AP
1988-03-09Manufacturing (CMC) · Supplement 11AP
1988-03-09Manufacturing (CMC) · Supplement 12AP
1988-01-13Manufacturing (CMC) · Supplement 9AP
1988-01-13Manufacturing (CMC) · Supplement 10AP
1985-10-17Manufacturing (CMC) · Supplement 7AP
1983-05-09OriginalAP
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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