APPLICATION
ANDA076899
TYPE
ANDA
ORIGINAL APPROVAL
2005-01-27
LATEST ACTION
2022-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIMPrescription
SULFAMETHOXAZOLE 400MG, TRIMETHOPRIM 80MG · TABLET · ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIMPrescription
SULFAMETHOXAZOLE 800MG, TRIMETHOPRIM 160MG · TABLET · ORAL
Approval history
2022-09-16Labeling · Supplement 26 · standardAP
2022-09-16Labeling · Supplement 29 · standardAP
2014-12-21Labeling · Supplement 13 · standardAP
2013-02-20Labeling · Supplement 12 · standardAP
2012-03-22Labeling · Supplement 11AP
2011-03-17Manufacturing (CMC) · Supplement 9AP
2008-03-20Manufacturing (CMC) · Supplement 2AP
2007-09-16Manufacturing (CMC) · Supplement 4AP
2007-08-14Labeling · Supplement 5AP
2005-01-27OriginalAP
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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