APPLICATION
ANDA070628
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-30
LATEST ACTION
2025-04-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIMDiscontinued
SULFAMETHOXAZOLE 80MG/ML, TRIMETHOPRIM 16MG/ML · INJECTABLE · INJECTION
Approval history
2025-04-08Labeling · Supplement 16 · standardAP
2023-07-13Labeling · Supplement 12 · standardAP
2023-07-13Labeling · Supplement 13 · standardAP
1998-11-05Manufacturing (CMC) · Supplement 9AP
1997-10-22Labeling · Supplement 8AP
1997-08-11Manufacturing (CMC) · Supplement 7AP
1990-07-25Labeling · Supplement 2AP
1988-03-28Manufacturing (CMC) · Supplement 5AP
1988-03-14Manufacturing (CMC) · Supplement 3AP
1988-02-23Labeling · Supplement 4AP
1987-04-30OriginalAP
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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