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FDA NDA · NDA218275

ZEVTERA

ceftobiprole medocaril sodium

Sponsor: ISTX

APPLICATION
NDA218275
TYPE
NDA
ORIGINAL APPROVAL
2024-04-03
LATEST ACTION
2026-06-26
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ZEVTERA · ReferencePrescription
CEFTOBIPROLE MEDOCARIL SODIUM 667MG/VIAL · POWDER · INTRAVENOUS

Approval history

2026-06-26Labeling · Supplement 1 · standardLetterAP
2024-04-03Type 1 - New Molecular Entity · Original · priorityLabelAP
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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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