APPLICATION
NDA050512
TYPE
NDA
ORIGINAL APPROVAL
1978-02-17
LATEST ACTION
2007-06-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DURICEF · ReferenceDiscontinued
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
DURICEFDiscontinued
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE · CAPSULE · ORAL
Approval history
1996-10-15Labeling · Supplement 43 · standardAP
1995-12-05Labeling · Supplement 42 · standardAP
1991-08-30Efficacy · Supplement 11AP
1989-05-18Labeling · Supplement 13AP
1988-09-12Manufacturing (CMC) · Supplement 14 · standardAP
1987-11-18Manufacturing (CMC) · Supplement 9 · standardAP
1986-09-12Labeling · Supplement 7AP
1983-07-08Manufacturing (CMC) · Supplement 3 · standardAP
1982-07-17Manufacturing (CMC) · Supplement 5 · standardAP
1982-05-21Manufacturing (CMC) · Supplement 2 · standardAP
1982-01-20Labeling · Supplement 40AP
1981-11-02Manufacturing (CMC) · Supplement 38 · standardAP
1981-11-02Manufacturing (CMC) · Supplement 39 · standardAP
1981-10-27Manufacturing (CMC) · Supplement 37 · standardAP
1981-08-24Manufacturing (CMC) · Supplement 36 · standardAP
1981-08-18Manufacturing (CMC) · Supplement 35 · standardAP
1981-04-21Labeling · Supplement 33AP
1981-04-03Labeling · Supplement 32AP
1980-05-05Manufacturing (CMC) · Supplement 22 · standardAP
1980-02-22Labeling · Supplement 31AP
1980-01-31Labeling · Supplement 30AP
1980-01-24Manufacturing (CMC) · Supplement 28 · standardAP
1980-01-21Manufacturing (CMC) · Supplement 29 · standardAP
1979-12-28Labeling · Supplement 27AP
1979-11-30Manufacturing (CMC) · Supplement 23 · standardAP
1979-10-25Labeling · Supplement 25AP
1979-04-26Manufacturing (CMC) · Supplement 24 · standardAP
1979-02-26Labeling · Supplement 21AP
1978-08-14Manufacturing (CMC) · Supplement 20 · standardAP
1978-07-21Manufacturing (CMC) · Supplement 19 · standardAP
1978-07-07Manufacturing (CMC) · Supplement 18 · standardAP
1978-05-08Labeling · Supplement 17AP
1978-05-08Labeling · Supplement 16AP
1978-02-17Type 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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