Home Applications 214662 Application 214662
Type NDA
Sponsor MIRUM PHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIVMARLI MARALIXIBAT CHLORIDE SOLUTION;ORAL 9.5MG No No 002 LIVMARLI MARALIXIBAT CHLORIDE SOLUTION;ORAL EQ 19MG BASE/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214662-001 LIVMARLI MARALIXIBAT CHLORIDE EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 N214662-002 LIVMARLI MARALIXIBAT CHLORIDE EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24
Orange Book patents# Current patent rows page 1 of 1 · 17 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 11 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-002 LIVMARLI EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N214662-001 11260053 2031-05-26 U-3974 2022-03-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-001 11260053 2031-05-26 U-3290 2022-03-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-001 10512657 2032-10-26 U-3850 2024-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-001 11229661 2032-10-26 U-3850 2024-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-001 11376251 2032-10-26 U-3290 2022-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-001 11376251 2032-10-26 U-3974 2022-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-001 11229647 2040-02-12 U-3974 2022-02-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-001 11229647 2040-02-12 U-3290 2022-02-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-001 11497745 2040-02-12 U-3974 2022-11-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-001 11497745 2040-02-12 U-3290 2022-11-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-001 11918578 2040-02-12 U-3290 2024-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-001 11918578 2040-02-12 U-3974 2024-03-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-001 12599602 2040-02-12 U-3974 2026-04-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-001 12599602 2040-02-12 U-3290 2026-04-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-002 10512657 2032-10-26 U-3973 2024-08-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-002 11229661 2032-10-26 U-3973 2024-08-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N214662-002 12350267 2032-10-26 U-3973 2025-08-05 a50c72e98297…
Observed Orange Book exclusivity history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 79378-110 Livmarli maralixibat chloride Mirum Pharmaceuticals Inc. NDA Current 79378-110 Livmarli maralixibat chloride Mirum Pharmaceuticals Inc. NDA Current 79378-110 Livmarli maralixibat chloride Mirum Pharmaceuticals Inc. NDA Current