APPLICATION
ANDA076346
TYPE
ANDA
ORIGINAL APPROVAL
2003-05-30
LATEST ACTION
2020-05-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TORSEMIDEPrescription
TORSEMIDE 100MG · TABLET · ORAL
TORSEMIDEPrescription
TORSEMIDE 10MG · TABLET · ORAL
TORSEMIDEPrescription
TORSEMIDE 20MG · TABLET · ORAL
TORSEMIDEPrescription
TORSEMIDE 5MG · TABLET · ORAL
Approval history
2020-05-04Labeling · Supplement 25 · standardAP
2012-12-12Labeling · Supplement 20 · standardAP
2011-09-21Labeling · Supplement 18AP
2004-10-19Manufacturing (CMC) · Supplement 6AP
2004-10-19Labeling · Supplement 7AP
2004-05-05Labeling · Supplement 5AP
2003-05-30OriginalAP
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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