APPLICATION
ANDA065308
TYPE
ANDA
ORIGINAL APPROVAL
2006-03-29
LATEST ACTION
2021-09-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CEFUROXIME AXETILPrescription
CEFUROXIME AXETIL EQ 250MG BASE · TABLET · ORAL
CEFUROXIME AXETILPrescription
CEFUROXIME AXETIL EQ 500MG BASE · TABLET · ORAL
CEFUROXIME AXETILPrescription
CEFUROXIME AXETIL EQ 125MG BASE · TABLET · ORAL
Approval history
2021-09-22Labeling · Supplement 20 · standardAP
2019-12-19Labeling · Supplement 16 · standardAP
2019-12-19Labeling · Supplement 15 · standardAP
2019-12-19Labeling · Supplement 13 · standardAP
2017-07-18Labeling · Supplement 11 · standardAP
2016-01-10Labeling · Supplement 10 · standardAP
2016-01-10Labeling · Supplement 8 · standardAP
2016-01-10Labeling · Supplement 9 · standardAP
2007-12-21Labeling · Supplement 1AP
2006-03-29OriginalAP
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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