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FDA NDA · NDA050528

DURICEF

Sponsor: WARNER CHILCOTT

APPLICATION
NDA050528
TYPE
NDA
ORIGINAL APPROVAL
1980-08-06
LATEST ACTION
2007-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DURICEF · ReferenceDiscontinued
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 1GM BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2007-06-05Labeling · Supplement 20 · standard — Label ↗AP
2003-12-16Labeling · Supplement 19 · standard — Letter ↗AP
2002-05-03Labeling · Supplement 18 · standard — Label ↗AP
1996-10-15Labeling · Supplement 17 · standardAP
1995-12-05Labeling · Supplement 16 · standardAP
1991-08-30Efficacy · Supplement 9AP
1990-02-28Labeling · Supplement 13AP
1988-09-12Manufacturing (CMC) · Supplement 10 · standardAP
1987-11-18Manufacturing (CMC) · Supplement 7 · standardAP
1986-09-12Labeling · Supplement 5AP
1983-07-08Manufacturing (CMC) · Supplement 3 · standardAP
1980-08-06Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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