APPLICATION
ANDA070890
TYPE
ANDA
ORIGINAL APPROVAL
1986-11-13
LATEST ACTION
2023-01-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIMDiscontinued
SULFAMETHOXAZOLE 400MG, TRIMETHOPRIM 80MG · TABLET · ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIMDiscontinued
SULFAMETHOXAZOLE 800MG, TRIMETHOPRIM 160MG · TABLET · ORAL
Approval history
2023-01-30Labeling · Supplement 10 · standardAP
2014-06-25Labeling · Supplement 9 · standardAP
1991-04-17Labeling · Supplement 7AP
1990-08-29Labeling · Supplement 6AP
1989-03-01Labeling · Supplement 5AP
1989-02-09Manufacturing (CMC) · Supplement 4AP
1987-09-22Manufacturing (CMC) · Supplement 2AP
1987-09-22Manufacturing (CMC) · Supplement 1AP
1986-11-13OriginalAP
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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