APPLICATION
ANDA070022
TYPE
ANDA
ORIGINAL APPROVAL
1985-02-15
LATEST ACTION
2025-09-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULFAMETHOPRIMDiscontinued
SULFAMETHOXAZOLE 400MG, TRIMETHOPRIM 80MG · TABLET · ORAL
Approval history
2025-09-28Labeling · Supplement 18 · standardAP
2025-09-28Labeling · Supplement 17 · standardAP
2022-09-22Labeling · Supplement 16 · standardAP
2022-09-22Labeling · Supplement 15 · standardAP
1995-05-10Manufacturing (CMC) · Supplement 14AP
1994-03-11Labeling · Supplement 13AP
1989-07-12Labeling · Supplement 12AP
1988-05-09Labeling · Supplement 11AP
1988-02-01Manufacturing (CMC) · Supplement 10AP
1986-11-28Manufacturing (CMC) · Supplement 9AP
1986-07-17Manufacturing (CMC) · Supplement 3AP
1986-05-29Manufacturing (CMC) · Supplement 6AP
1986-05-29Manufacturing (CMC) · Supplement 5AP
1985-02-15OriginalAP
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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