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FDA ANDA · ANDA078249

TORSEMIDE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA078249
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-17
LATEST ACTION
2020-05-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TORSEMIDEPrescription
TORSEMIDE 20MG · TABLET · ORAL
TORSEMIDEPrescription
TORSEMIDE 5MG · TABLET · ORAL
TORSEMIDEPrescription
TORSEMIDE 100MG · TABLET · ORAL
TORSEMIDEPrescription
TORSEMIDE 10MG · TABLET · ORAL

Approval history

2020-05-04Labeling · Supplement 9 · standardAP
2012-09-30Manufacturing (CMC) · Supplement 1AP
2012-09-18Labeling · Supplement 4 · standardAP
2011-09-22Labeling · Supplement 2AP
2007-10-17OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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