APPLICATION
ANDA073303
TYPE
ANDA
ORIGINAL APPROVAL
1991-10-31
LATEST ACTION
2026-02-10
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIMPrescription
SULFAMETHOXAZOLE 80MG/ML, TRIMETHOPRIM 16MG/ML · INJECTABLE · INJECTION
Approval history
2026-02-10Labeling · Supplement 46 · standardAP
2025-02-24Labeling · Supplement 45 · standardAP
2025-02-21Labeling · Supplement 38 · standardAP
2025-02-21Labeling · Supplement 43 · standardAP
2013-04-29Labeling · Supplement 23AP
2013-02-27Labeling · Supplement 28 · standardAP
2002-07-23Labeling · Supplement 8AP
1998-08-26Labeling · Supplement 7AP
1996-12-27Manufacturing (CMC) · Supplement 6AP
1996-10-03Manufacturing (CMC) · Supplement 5AP
1993-11-03Manufacturing (CMC) · Supplement 3AP
1993-04-26Labeling · Supplement 4AP
1993-04-05Manufacturing (CMC) · Supplement 2AP
1992-08-07Manufacturing (CMC) · Supplement 1AP
1991-10-31OriginalAP
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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