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FDA NDA · NDA050686

CEDAX

Sponsor: BURKE THERAP

APPLICATION
NDA050686
TYPE
NDA
ORIGINAL APPROVAL
1995-12-20
LATEST ACTION
2011-03-11
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

CEDAX · ReferenceDiscontinued
CEFTIBUTEN DIHYDRATE EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
CEDAX · ReferenceDiscontinued
CEFTIBUTEN DIHYDRATE EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL

Approval history

2011-03-11Manufacturing (CMC) · Supplement 16 · standard — Label ↗AP
2010-11-04Labeling · Supplement 15 · standard — Letter ↗AP
2009-02-10Labeling · Supplement 14 · standard — Label ↗AP
2001-01-04Manufacturing (CMC) · Supplement 11 · standardAP
2000-05-19Labeling · Supplement 9 · standardAP
1999-02-16Labeling · Supplement 6 · standardAP
1998-10-02Manufacturing (CMC) · Supplement 8 · standardAP
1998-06-15Labeling · Supplement 7 · standardAP
1998-03-03Manufacturing (CMC) · Supplement 5 · standardAP
1997-09-03Manufacturing (CMC) · Supplement 4 · standardAP
1997-05-21Labeling · Supplement 2 · standardAP
1996-10-09Labeling · Supplement 1 · standardAP
1996-09-10Manufacturing (CMC) · Supplement 3 · standardAP
1995-12-20Type 3 - New Dosage Form · Original · standardAP
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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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