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FDA NDA · NDA219491

NUZOLVENCE

zoliflodacin

Sponsor: ENTASIS THERAP

APPLICATION
NDA219491
TYPE
NDA
ORIGINAL APPROVAL
2025-12-12
LATEST ACTION
2025-12-12
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

NUZOLVENCE · ReferencePrescription
ZOLIFLODACIN 3GM/PACKET · FOR SUSPENSION · ORAL

Approval history

2025-12-12Type 1 - New Molecular Entity · Original · priorityLetterAP
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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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