APPLICATION
NDA020136
TYPE
NDA
ORIGINAL APPROVAL
1993-08-23
LATEST ACTION
2017-02-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DEMADEX · ReferenceDiscontinued
TORSEMIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DEMADEX · ReferenceDiscontinued
TORSEMIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DEMADEX · ReferenceDiscontinued
TORSEMIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DEMADEX · ReferenceDiscontinued
TORSEMIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2013-11-22Manufacturing (CMC) · Supplement 26 · standardAP
2012-11-16Manufacturing (CMC) · Supplement 25 · standardAP
2002-09-17Manufacturing (CMC) · Supplement 19 · standardAP
1998-04-20Manufacturing (CMC) · Supplement 17 · standardAP
1998-03-16Manufacturing (CMC) · Supplement 16 · standardAP
1998-02-13Labeling · Supplement 11 · standardAP
1998-01-07Manufacturing (CMC) · Supplement 15 · standardAP
1997-11-26Manufacturing (CMC) · Supplement 14 · standardAP
1997-10-01Manufacturing (CMC) · Supplement 13 · standardAP
1997-05-30Manufacturing (CMC) · Supplement 12 · standardAP
1996-10-30Manufacturing (CMC) · Supplement 10 · standardAP
1996-02-14Manufacturing (CMC) · Supplement 4 · standardAP
1995-11-30Manufacturing (CMC) · Supplement 8 · standardAP
1995-11-15Manufacturing (CMC) · Supplement 5 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 7 · standardAP
1995-10-24Manufacturing (CMC) · Supplement 6 · standardAP
1995-09-05Labeling · Supplement 1 · standardAP
1995-08-09Manufacturing (CMC) · Supplement 2 · standardAP
1995-05-12Manufacturing (CMC) · Supplement 3 · standardAP
1993-08-23Type 1 - New Molecular Entity · Original · standardAP
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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