APPLICATION
ANDA065135
TYPE
ANDA
ORIGINAL APPROVAL
2003-07-25
LATEST ACTION
2022-05-27
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
2022-05-27Labeling · Supplement 26 · standardAP
2019-12-19Labeling · Supplement 24 · standardAP
2019-12-19Labeling · Supplement 22 · standardAP
2017-07-18Labeling · Supplement 20 · standardAP
2016-03-24Labeling · Supplement 17 · standardAP
2016-03-24Labeling · Supplement 18 · standardAP
2015-02-25Labeling · Supplement 15 · standardAP
2008-09-18Labeling · Supplement 3AP
2008-08-18Labeling · Supplement 6AP
2007-10-30Labeling · Supplement 2AP
2005-04-26Labeling · Supplement 1AP
2003-07-25OriginalAP
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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