APPLICATION
NDA050522
TYPE
NDA
ORIGINAL APPROVAL
1979-04-04
LATEST ACTION
2004-03-17
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
CECLOR · ReferenceDiscontinued
CEFACLOR EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
CECLOR · ReferenceDiscontinued
CEFACLOR EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
Approval history
2001-10-12Labeling · Supplement 23 · standardAP
2000-04-27Manufacturing (CMC) · Supplement 22 · standardAP
2000-03-16Manufacturing (CMC) · Supplement 20 · standardAP
2000-03-13Manufacturing (CMC) · Supplement 21 · standardAP
1998-09-18Labeling · Supplement 19 · standardAP
1996-09-30Labeling · Supplement 14 · standardAP
1996-05-01Labeling · Supplement 8 · standardAP
1996-05-01Labeling · Supplement 7 · standardAP
1996-03-06Labeling · Supplement 13 · standardAP
1996-03-05Labeling · Supplement 15 · standardAP
1995-04-13Labeling · Supplement 11 · standardAP
1993-05-28Labeling · Supplement 12 · standardAP
1992-12-08Manufacturing (CMC) · Supplement 10 · standardAP
1988-07-21Labeling · Supplement 6 · standardAP
1986-08-28Labeling · Supplement 2 · standardAP
1986-07-14Labeling · Supplement 1 · standardAP
1979-04-04Type 2 - New Active Ingredient · 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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