APPLICATION
ANDA065166
TYPE
ANDA
ORIGINAL APPROVAL
2005-07-29
LATEST ACTION
2025-09-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CEFUROXIME AXETILPrescription
CEFUROXIME AXETIL EQ 500MG BASE · TABLET · ORAL
CEFUROXIME AXETILPrescription
CEFUROXIME AXETIL EQ 125MG BASE · TABLET · ORAL
CEFUROXIME AXETILPrescription
CEFUROXIME AXETIL EQ 250MG BASE · TABLET · ORAL
Approval history
2025-09-25Labeling · Supplement 6 · standardAP
2025-09-25Labeling · Supplement 4 · standardAP
2025-09-25Labeling · Supplement 3 · standardAP
2017-07-18Labeling · Supplement 2 · standardAP
2005-07-29OriginalAP
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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