APPLICATION
NDA050673
TYPE
NDA
ORIGINAL APPROVAL
1996-06-28
LATEST ACTION
2000-12-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
CECLOR CDDiscontinued
CEFACLOR EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
CECLOR CDDiscontinued
CEFACLOR EQ 375MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
Approval history
2000-12-08Manufacturing (CMC) · Supplement 7 · standardAP
2000-04-27Manufacturing (CMC) · Supplement 6 · standardAP
2000-04-04Manufacturing (CMC) · Supplement 5 · standardAP
2000-03-13Manufacturing (CMC) · Supplement 4 · standardAP
1999-11-08Manufacturing (CMC) · Supplement 3 · standardAP
1998-02-26Manufacturing (CMC) · Supplement 2 · standardAP
1997-06-24Manufacturing (CMC) · Supplement 1 · standardAP
1996-06-28Type 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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