Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219485
Company: MIRUM

Products on NDA 219485

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIVMARLI	MARALIXIBAT CHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	None	Yes	No
LIVMARLI	MARALIXIBAT CHLORIDE	EQ 15MG BASE	TABLET;ORAL	Prescription	None	Yes	No
LIVMARLI	MARALIXIBAT CHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	None	Yes	No
LIVMARLI	MARALIXIBAT CHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 219485

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/10/2025	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219485s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219485Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/219485Orig1s000TOC.html

Labels for NDA 219485

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/10/2025	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219485s000lbl.pdf