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FDA NDA · NDA020137

DEMADEX

Sponsor: ROCHE

APPLICATION
NDA020137
TYPE
NDA
ORIGINAL APPROVAL
1993-08-23
LATEST ACTION
1998-04-20
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

DEMADEX · ReferenceDiscontinued
TORSEMIDE 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
DEMADEX · ReferenceDiscontinued
TORSEMIDE 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

1998-04-20Manufacturing (CMC) · Supplement 13 · standardAP
1998-02-13Efficacy · Supplement 9 · standardAP
1998-01-07Manufacturing (CMC) · Supplement 12 · standardAP
1997-11-26Manufacturing (CMC) · Supplement 11 · standardAP
1997-10-01Manufacturing (CMC) · Supplement 10 · standardAP
1997-09-09Efficacy · Supplement 8 · standard — Review ↗AP
1996-06-17Manufacturing (CMC) · Supplement 7 · standardAP
1995-11-15Manufacturing (CMC) · Supplement 4 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 6 · standardAP
1995-10-24Manufacturing (CMC) · Supplement 5 · standardAP
1995-09-05Labeling · Supplement 1 · standardAP
1995-08-09Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
1995-05-12Manufacturing (CMC) · Supplement 3 · standardAP
1993-08-23Type 3 - New Dosage Form · Original · standardAP
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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