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FDA NDA · NDA209445

FETROJA

cefiderocol sulfate tosylate

Sponsor: SHIONOGI

APPLICATION
NDA209445
TYPE
NDA
ORIGINAL APPROVAL
2019-11-14
LATEST ACTION
2026-07-01
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

FETROJA · ReferencePrescription
CEFIDEROCOL SULFATE TOSYLATE EQ 1GM BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2026-07-01Labeling · Supplement 12 · standard — Letter ↗AP
2025-06-06Labeling · Supplement 9 · standard — Label ↗AP
2021-11-12Labeling · Supplement 4 · standard — Letter ↗AP
2020-09-25Efficacy · Supplement 2 · priority — Label ↗AP
2019-11-14Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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