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FDA NDA · NDA213218

SOAANZ

torsemide

Sponsor: SARFE PHARMS

APPLICATION
NDA213218
TYPE
NDA
ORIGINAL APPROVAL
2021-06-14
LATEST ACTION
2021-11-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

SOAANZ · ReferenceDiscontinued
TORSEMIDE 60MG · TABLET · ORAL
SOAANZ · ReferencePrescription
TORSEMIDE 40MG · TABLET · ORAL
SOAANZ · ReferenceDiscontinued
TORSEMIDE 20MG · TABLET · ORAL

Approval history

2021-11-17Manufacturing (CMC) · Supplement 1LabelAP
2021-06-14Type 5 - New Formulation or New Manufacturer · Original · standardLetterAP
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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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