APPLICATION
ANDA064148
TYPE
ANDA
ORIGINAL APPROVAL
1996-05-23
LATEST ACTION
2021-08-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
CEFACLORDiscontinued
CEFACLOR EQ 500MG BASE · CAPSULE · ORAL
CEFACLORDiscontinued
CEFACLOR EQ 250MG BASE · CAPSULE · ORAL
Approval history
2021-08-04Labeling · Supplement 6 · standardAP
2021-08-04Labeling · Supplement 7 · standardAP
2000-12-08Manufacturing (CMC) · Supplement 5AP
1999-05-03Labeling · Supplement 4AP
1998-11-05Labeling · Supplement 2AP
1998-01-26Manufacturing (CMC) · Supplement 3AP
1997-01-10Manufacturing (CMC) · Supplement 1AP
1996-05-23OriginalAP
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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