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FDA ANDA · ANDA078060
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Sponsor: CHARTWELL MOLECULES
APPLICATION
ANDA078060
TYPE
ANDA
ORIGINAL APPROVAL
2007-01-25
LATEST ACTION
2022-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIMPrescription
SULFAMETHOXAZOLE 800MG, TRIMETHOPRIM 160MG · TABLET · ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIMPrescription
SULFAMETHOXAZOLE 400MG, TRIMETHOPRIM 80MG · TABLET · ORAL
Approval history
2022-09-16Labeling · Supplement 20 · standardAP
2014-12-21Labeling · Supplement 16 · standardAP
2014-10-23Manufacturing (CMC) · Supplement 13AP
2012-12-05Labeling · Supplement 14 · standardAP
2010-09-28Labeling · Supplement 6AP
2007-10-19Labeling · Supplement 2AP
2007-02-27Labeling · Supplement 1AP
2007-01-25OriginalAP
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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