APPLICATION
ANDA065238
TYPE
ANDA
ORIGINAL APPROVAL
2010-03-12
LATEST ACTION
2019-12-30
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CEFOXITINPrescription
CEFOXITIN SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
CEFOXITINPrescription
CEFOXITIN SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2019-12-30Labeling · Supplement 7 · standardAP
2019-12-30Labeling · Supplement 5 · standardAP
2019-12-30Labeling · Supplement 3 · standardAP
2010-03-12OriginalAP
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.