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FDA NDA · NDA216109

CEFAZOLIN

Sponsor: HIKMA

APPLICATION
NDA216109
TYPE
NDA
ORIGINAL APPROVAL
2022-10-07
LATEST ACTION
2024-12-18
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

CEFAZOLIN SODIUM · ReferencePrescription
CEFAZOLIN SODIUM EQ 2GM BASE/VIAL · POWDER · INTRAVENOUS
CEFAZOLIN SODIUM · ReferencePrescription
CEFAZOLIN SODIUM EQ 3GM BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2024-12-18Efficacy · Supplement 3 · standard — Label ↗AP
2022-10-07Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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