FDA NDA · NDA050685

CEDAX

Sponsor: BURKE THERAP

APPLICATION

NDA050685

TYPE

NDA

ORIGINAL APPROVAL

1995-12-20

LATEST ACTION

2010-11-04

ROUTE

ORAL

DOSAGE FORM

CAPSULE

MARKETING STATUS

Discontinued

Products

CEDAXDiscontinued

CEFTIBUTEN DIHYDRATE EQ 400MG BASE · CAPSULE · ORAL

2010-11-04Labeling · Supplement 12 · standard — Letter ↗AP

2009-02-10Labeling · Supplement 11 · standard — Label ↗AP

2000-05-19Labeling · Supplement 8 · standardAP

1999-07-23Manufacturing (CMC) · Supplement 7 · standardAP

1999-02-16Labeling · Supplement 6 · standardAP

1997-09-03Manufacturing (CMC) · Supplement 5 · standardAP

1997-05-21Labeling · Supplement 3 · standardAP

1996-12-26Manufacturing (CMC) · Supplement 4 · standardAP

1996-10-09Labeling · Supplement 1 · standardAP

1995-12-20Type 1 - New Molecular Entity · Original · standard — Review ↗AP

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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