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FDA ANDA · ANDA076894

TORSEMIDE

Sponsor: COREPHARMA

APPLICATION
ANDA076894
TYPE
ANDA
ORIGINAL APPROVAL
2005-05-31
LATEST ACTION
2013-05-06
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

2013-05-06Labeling · Supplement 8 · standardAP
2010-09-28Labeling · Supplement 7AP
2008-05-09Supplement · Supplement 3 — Review ↗AP
2008-04-10Supplement · Supplement 4 — Review ↗AP
2007-11-07Supplement · Supplement 2 — Review ↗AP
2007-10-03Manufacturing (CMC) · Supplement 1 — Review ↗AP
2005-05-31Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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