APPLICATION
ANDA065046
TYPE
ANDA
ORIGINAL APPROVAL
2004-01-09
LATEST ACTION
2021-07-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CEFUROXIME SODIUMDiscontinued
CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-07-07Labeling · Supplement 13 · standardAP
2021-07-07Labeling · Supplement 12 · standardAP
2019-11-16Labeling · Supplement 11 · standardAP
2016-05-06Labeling · Supplement 9 · standardAP
2008-08-25Labeling · Supplement 3AP
2004-01-09OriginalAP
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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