APPLICATION
ANDA065047
TYPE
ANDA
ORIGINAL APPROVAL
2001-09-18
LATEST ACTION
2025-12-01
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CEFAZOLIN SODIUMPrescription
CEFAZOLIN SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
CEFAZOLIN SODIUMPrescription
CEFAZOLIN SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2025-12-01Manufacturing (CMC) · Supplement 34 · standardAP
2025-08-21Labeling · Supplement 18 · standardAP
2025-08-21Labeling · Supplement 16 · standardAP
2025-08-21Labeling · Supplement 21 · standardAP
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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