APPLICATION
NDA050527
TYPE
NDA
ORIGINAL APPROVAL
1980-09-12
LATEST ACTION
2007-06-05
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
DURICEF · ReferenceDiscontinued
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
DURICEF · ReferenceDiscontinued
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
DURICEF · ReferenceDiscontinued
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
Approval history
1999-03-26Manufacturing (CMC) · Supplement 19 · standardAP
1996-10-15Labeling · Supplement 17 · standardAP
1995-12-05Labeling · Supplement 16 · standardAP
1991-08-30Efficacy · Supplement 9AP
1989-05-03Labeling · Supplement 11AP
1988-09-12Manufacturing (CMC) · Supplement 10 · standardAP
1987-03-05Manufacturing (CMC) · Supplement 6 · standardAP
1982-05-21Manufacturing (CMC) · Supplement 15 · standardAP
1982-01-20Labeling · Supplement 12AP
1981-10-27Manufacturing (CMC) · Supplement 8 · standardAP
1981-08-07Labeling · Supplement 5AP
1981-06-30Labeling · Supplement 4AP
1981-03-31Labeling · Supplement 3AP
1980-12-08Manufacturing (CMC) · Supplement 2 · standardAP
1980-11-04Labeling · Supplement 1AP
1980-09-12Type 3 - New Dosage Form · 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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