APPLICATION
ANDA076226
TYPE
ANDA
ORIGINAL APPROVAL
2003-05-27
LATEST ACTION
2024-08-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TORSEMIDEDiscontinued
TORSEMIDE 20MG · TABLET · ORAL
TORSEMIDEDiscontinued
TORSEMIDE 5MG · TABLET · ORAL
TORSEMIDEDiscontinued
TORSEMIDE 100MG · TABLET · ORAL
TORSEMIDEDiscontinued
TORSEMIDE 10MG · TABLET · ORAL
Approval history
2024-08-16Labeling · Supplement 5 · standardAP
2005-06-16Labeling · Supplement 2AP
2003-05-27OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.