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 42 .
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.
Product history page 1 of 2 · 47 observed 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 2026-08-18 06:07:40 2026-07 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-002 LIVMARLI EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-002 LIVMARLI EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214662-002 LIVMARLI EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214662-002 LIVMARLI EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214662-002 LIVMARLI EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214662-002 LIVMARLI EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214662-002 LIVMARLI EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214662-002 LIVMARLI EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214662-002 LIVMARLI EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214662-002 LIVMARLI EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214662-002 LIVMARLI EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214662-002 LIVMARLI EQ 19MG BASE/ML SOLUTION / ORAL RLD, RS 2024-07-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214662-001 LIVMARLI EQ 9.5MG BASE/ML SOLUTION / ORAL RLD, RS 2021-09-29 053a50430f4f…
Observed Orange Book patent history# Patent history page 1 of 7 · 259 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N214662-001 11260053 2031-05-26 U-3974 2022-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-001 11260053 2031-05-26 U-3290 2022-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-001 10512657 2032-10-26 U-3850 2024-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-001 11229661 2032-10-26 U-3850 2024-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-001 11376251 2032-10-26 U-3290 2022-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-001 11376251 2032-10-26 U-3974 2022-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-001 11229647 2040-02-12 U-3974 2022-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-001 11229647 2040-02-12 U-3290 2022-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-001 11497745 2040-02-12 U-3974 2022-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-001 11497745 2040-02-12 U-3290 2022-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-001 11918578 2040-02-12 U-3290 2024-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-001 11918578 2040-02-12 U-3974 2024-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-001 12599602 2040-02-12 U-3974 2026-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-001 12599602 2040-02-12 U-3290 2026-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-002 10512657 2032-10-26 U-3973 2024-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-002 11229661 2032-10-26 U-3973 2024-08-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214662-002 12350267 2032-10-26 U-3973 2025-08-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214662-001 11260053 2031-05-26 U-3974 2022-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-001 11260053 2031-05-26 U-3290 2022-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-001 10512657 2032-10-26 U-3850 2024-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-001 11229661 2032-10-26 U-3850 2024-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-001 11376251 2032-10-26 U-3290 2022-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-001 11376251 2032-10-26 U-3974 2022-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-001 11229647 2040-02-12 U-3974 2022-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-001 11229647 2040-02-12 U-3290 2022-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-001 11497745 2040-02-12 U-3974 2022-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-001 11497745 2040-02-12 U-3290 2022-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-001 11918578 2040-02-12 U-3290 2024-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-001 11918578 2040-02-12 U-3974 2024-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-002 10512657 2032-10-26 U-3973 2024-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-002 11229661 2032-10-26 U-3973 2024-08-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214662-002 12350267 2032-10-26 U-3973 2025-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214662-001 11260053 2031-05-26 U-3974 2022-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214662-001 11260053 2031-05-26 U-3290 2022-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214662-001 10512657 2032-10-26 U-3850 2024-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214662-001 11229661 2032-10-26 U-3850 2024-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214662-001 11376251 2032-10-26 U-3290 2022-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214662-001 11376251 2032-10-26 U-3974 2022-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214662-001 11229647 2040-02-12 U-3974 2022-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214662-001 11229647 2040-02-12 U-3290 2022-02-01 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 201 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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