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FDA NDA · NDA217417

REZZAYO

rezafungin

Sponsor: MUNDIPHARMA

APPLICATION
NDA217417
TYPE
NDA
ORIGINAL APPROVAL
2023-03-22
LATEST ACTION
2026-07-16
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

REZZAYO · ReferencePrescription
REZAFUNGIN ACETATE EQ 200MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2026-07-16Efficacy · Supplement 7 · standard — Letter ↗AP
2025-12-10Labeling · Supplement 8 · standard — Letter ↗AP
2023-03-22Type 1 - New Molecular Entity · Original · priority — 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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