APPLICATION
ANDA064125
TYPE
ANDA
ORIGINAL APPROVAL
1997-05-30
LATEST ACTION
2021-10-08
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CEFUROXIME SODIUMPrescription
CEFUROXIME SODIUM EQ 750MG BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
CEFUROXIME SODIUMPrescription
CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-10-08Labeling · Supplement 13 · standardAP
2016-04-12Labeling · Supplement 9 · standardAP
2012-11-21Labeling · Supplement 6AP
2007-01-31Labeling · Supplement 5AP
2004-08-23Labeling · Supplement 3AP
1999-09-23Manufacturing (CMC) · Supplement 1AP
1997-05-30OriginalAP
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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