APPLICATION
ANDA065048
TYPE
ANDA
ORIGINAL APPROVAL
2004-01-09
LATEST ACTION
2021-07-07
ROUTE
INTRAVENOUS, INTRAMUSCULAR, Injection, INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
Injectable, INJECTABLE
MARKETING STATUS
Prescription
Products
CEFUROXIMEPrescription
CEFUROXIME 1.5G/20ML · Injectable · Injection
CEFUROXIME SODIUMPrescription
CEFUROXIME SODIUM EQ 750MG BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
CEFUROXIMEPrescription
CEFUROXIME 1.5G/100ML · Injectable · Injection
CEFUROXIME SODIUMPrescription
CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-07-07Labeling · Supplement 19 · standardAP
2021-07-07Labeling · Supplement 18 · standardAP
2019-11-16Labeling · Supplement 17 · standardAP
2016-04-12Labeling · Supplement 14 · standardAP
2008-01-16Labeling · Supplement 8AP
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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