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FDA NDA · NDA214662

LIVMARLI

maralixibat chloride

Sponsor: MIRUM

APPLICATION
NDA214662
TYPE
NDA
ORIGINAL APPROVAL
2021-09-29
LATEST ACTION
2024-11-08
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

LIVMARLI · ReferencePrescription
MARALIXIBAT CHLORIDE EQ 9.5MG BASE/ML · SOLUTION · ORAL
LIVMARLI · ReferencePrescription
MARALIXIBAT CHLORIDE EQ 19MG BASE/ML · SOLUTION · ORAL

Approval history

2024-11-08Labeling · Supplement 11 · standard — Label ↗AP
2024-07-24Efficacy · Supplement 10 · standard — Letter ↗AP
2024-07-24Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2024-03-13Efficacy · Supplement 5 · standard — Letter ↗AP
2024-03-13Labeling · Supplement 8 · standard — Letter ↗AP
2023-03-13Efficacy · Supplement 4 · priority — Letter ↗AP
2022-04-01Labeling · Supplement 1 · standard — Letter ↗AP
2021-09-29Type 1 - New Molecular Entity · Original · priority — Label ↗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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