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FDA NDA · NDA219485

LIVMARLI

maralixibat chloride

Sponsor: MIRUM

APPLICATION
NDA219485
TYPE
NDA
ORIGINAL APPROVAL
2025-04-10
LATEST ACTION
2025-04-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LIVMARLI · ReferencePrescription
MARALIXIBAT CHLORIDE EQ 30MG BASE · TABLET · ORAL
LIVMARLI · ReferencePrescription
MARALIXIBAT CHLORIDE EQ 15MG BASE · TABLET · ORAL
LIVMARLI · ReferencePrescription
MARALIXIBAT CHLORIDE EQ 20MG BASE · TABLET · ORAL
LIVMARLI · ReferencePrescription
MARALIXIBAT CHLORIDE EQ 10MG BASE · TABLET · ORAL

Approval history

2025-04-10Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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