APPLICATION
ANDA065496
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-07
LATEST ACTION
2022-05-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CEFUROXIME AXETILPrescription
CEFUROXIME AXETIL EQ 500MG BASE · TABLET · ORAL
CEFUROXIME AXETILPrescription
CEFUROXIME AXETIL EQ 250MG BASE · TABLET · ORAL
Approval history
2022-05-27Labeling · Supplement 15 · standardAP
2019-12-19Labeling · Supplement 12 · standardAP
2019-12-19Labeling · Supplement 10 · standardAP
2017-04-19Manufacturing (CMC) · Supplement 6 · unknownAP
2017-03-10Labeling · Supplement 7 · standardAP
2016-03-24Labeling · Supplement 4 · standardAP
2010-06-07OriginalAP
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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