APPLICATION
ANDA065069
TYPE
ANDA
ORIGINAL APPROVAL
2002-10-02
LATEST ACTION
2022-06-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CEFUROXIME AXETILDiscontinued
CEFUROXIME AXETIL EQ 500MG BASE · TABLET · ORAL
CEFUROXIME AXETILDiscontinued
CEFUROXIME AXETIL EQ 250MG BASE · TABLET · ORAL
Approval history
2022-06-09Labeling · Supplement 17 · standardAP
2019-12-19Labeling · Supplement 15 · standardAP
2019-12-19Labeling · Supplement 16 · standardAP
2017-07-11Labeling · Supplement 14 · standardAP
2016-03-24Labeling · Supplement 13 · standardAP
2015-09-22Labeling · Supplement 12 · standardAP
2009-01-06Labeling · Supplement 9AP
2005-09-01Labeling · Supplement 5AP
2002-10-02OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.