APPLICATION
ANDA065058
TYPE
ANDA
ORIGINAL APPROVAL
2002-09-04
LATEST ACTION
2021-07-27
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
CEFACLORPrescription
CEFACLOR EQ 500MG BASE · TABLET, EXTENDED RELEASE · ORAL
CEFACLORPrescription
CEFACLOR EQ 375MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2021-07-27Labeling · Supplement 11 · standardAP
2015-07-24Labeling · Supplement 9 · standardAP
2010-04-27Labeling · Supplement 7AP
2003-09-22Labeling · Supplement 2AP
2002-09-04OriginalAP
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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