Drug application

LIVMARLI (MARALIXIBAT CHLORIDE)

Drugs@FDA NDA 219485 · MIRUM

Key facts

Drug name LIVMARLI
Active ingredients MARALIXIBAT CHLORIDE
Application type NDA
Application number 219485
Company MIRUM
Dosage forms TABLET, ORAL
Strength EQ 10MG BASE
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Apr 10, 2025

At a glance

  • 1–9 Submissions
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

Browse all Drugs@FDA applications