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 44.

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.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N214662-001	11260053	2031-05-26	U-3290	2022-03-01
N214662-001	11260053	2031-05-26	U-3974	2022-03-01
N214662-001	10512657	2032-10-26	U-3850	2024-03-22
N214662-001	11229661	2032-10-26	U-3850	2024-03-22
N214662-001	11376251	2032-10-26	U-3290	2022-07-19
N214662-001	11376251	2032-10-26	U-3974	2022-07-19
N214662-001	11229647	2040-02-12	U-3290	2022-02-01
N214662-001	11229647	2040-02-12	U-3974	2022-02-01
N214662-001	11497745	2040-02-12	U-3290	2022-11-30
N214662-001	11497745	2040-02-12	U-3974	2022-11-30
N214662-001	11918578	2040-02-12	U-3290	2024-03-22
N214662-001	11918578	2040-02-12	U-3974	2024-03-22
N214662-001	12599602	2040-02-12	U-3290	2026-04-22
N214662-001	12599602	2040-02-12	U-3974	2026-04-22
N214662-002	10512657	2032-10-26	U-3973	2024-08-23
N214662-002	11229661	2032-10-26	U-3973	2024-08-23
N214662-002	12350267	2032-10-26	U-3973	2025-08-05

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 11 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214662-001	NPP	2026-03-13
N214662-001	NCE	2026-09-29
N214662-001	I-938	2027-03-13
N214662-001	ODE-379	2028-09-29
N214662-001	ODE-429	2030-03-13
N214662-001	ODE-471	2031-03-13
N214662-002	NCE	2026-09-29
N214662-002	ODE*	2028-09-29
N214662-002	ODE*	2030-03-13
N214662-002	ODE*	2031-03-13
N214662-002	ODE-490	2031-07-24

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 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N214662-001	LIVMARLI	EQ 9.5MG BASE/ML	SOLUTION / ORAL	RLD, RS	2021-09-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-002	LIVMARLI	EQ 19MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N214662-001	LIVMARLI	EQ 9.5MG BASE/ML	SOLUTION / ORAL	RLD, RS	2021-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-002	LIVMARLI	EQ 19MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-07-24	`84e616aacf4f…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 293 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N214662-001	11260053	2031-05-26	U-3974	2022-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-001	11260053	2031-05-26	U-3290	2022-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-001	10512657	2032-10-26	U-3850	2024-03-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-001	11229661	2032-10-26	U-3850	2024-03-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-001	11376251	2032-10-26	U-3290	2022-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-001	11376251	2032-10-26	U-3974	2022-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-001	11229647	2040-02-12	U-3974	2022-02-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-001	11229647	2040-02-12	U-3290	2022-02-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-001	11497745	2040-02-12	U-3974	2022-11-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-001	11497745	2040-02-12	U-3290	2022-11-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-001	11918578	2040-02-12	U-3290	2024-03-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-001	11918578	2040-02-12	U-3974	2024-03-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-001	12599602	2040-02-12	U-3974	2026-04-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-001	12599602	2040-02-12	U-3290	2026-04-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-002	10512657	2032-10-26	U-3973	2024-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-002	11229661	2032-10-26	U-3973	2024-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214662-002	12350267	2032-10-26	U-3973	2025-08-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N214662-001	11260053	2031-05-26	U-3974	2022-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-001	11260053	2031-05-26	U-3290	2022-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-001	10512657	2032-10-26	U-3850	2024-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-001	11229661	2032-10-26	U-3850	2024-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-001	11376251	2032-10-26	U-3290	2022-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-001	11376251	2032-10-26	U-3974	2022-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-001	11229647	2040-02-12	U-3974	2022-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-001	11229647	2040-02-12	U-3290	2022-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-001	11497745	2040-02-12	U-3974	2022-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-001	11497745	2040-02-12	U-3290	2022-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-001	11918578	2040-02-12	U-3290	2024-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-001	11918578	2040-02-12	U-3974	2024-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-001	12599602	2040-02-12	U-3974	2026-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-001	12599602	2040-02-12	U-3290	2026-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-002	10512657	2032-10-26	U-3973	2024-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-002	11229661	2032-10-26	U-3973	2024-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214662-002	12350267	2032-10-26	U-3973	2025-08-05	`84e616aacf4f…`
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…`

Observed Orange Book exclusivity history#

Exclusivity history page 3 of 6 · 223 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214662-001	ODE-379	2028-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214662-001	ODE-429	2030-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214662-001	ODE-471	2031-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214662-002	NCE	2026-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214662-002	ODE*	2028-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214662-002	ODE*	2030-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214662-002	ODE*	2031-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214662-002	ODE-490	2031-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214662-001	NPP	2026-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214662-001	NCE	2026-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214662-001	I-938	2027-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214662-001	ODE-379	2028-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214662-001	ODE-429	2030-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214662-001	ODE-471	2031-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214662-002	NCE	2026-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214662-002	ODE*	2028-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214662-002	ODE*	2030-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214662-002	ODE*	2031-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214662-002	ODE-490	2031-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214662-001	NPP	2026-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214662-001	NCE	2026-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214662-001	I-938	2027-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214662-001	ODE-379	2028-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214662-001	ODE-429	2030-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214662-001	ODE-471	2031-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214662-002	NCE	2026-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214662-002	ODE*	2028-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214662-002	ODE*	2030-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214662-002	ODE*	2031-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214662-002	ODE-490	2031-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214662-001	NPP	2026-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214662-001	NCE	2026-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214662-001	I-938	2027-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214662-001	ODE-379	2028-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214662-001	ODE-429	2030-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214662-001	ODE-471	2031-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214662-002	NCE	2026-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214662-001	NPP	2026-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214662-001	NCE	2026-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214662-001	I-938	2027-03-13	`d8e5a09893c0…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Livmarli	MARALIXIBAT CHLORIDE	Mirum Pharmaceuticals Inc.	64000394-1ef6-4e76-8ba8-11f25ba1b167	2025-04-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214662 application number: NDA214662 ndc (product): 79378-110

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79234	SUPPL	2026-04-15
79233	SUPPL	2026-04-15
80198	SUPPL	2024-11-12
80189	SUPPL	2024-11-12
79210	SUPPL	2024-07-25
79209	SUPPL	2024-07-25
77834	SUPPL	2024-03-14
77833	SUPPL	2024-03-14
77830	SUPPL	2024-03-14
77829	SUPPL	2024-03-14
73758	SUPPL	2023-03-14
73742	SUPPL	2023-03-14
70704	SUPPL	2022-04-05
70684	SUPPL	2022-04-04
69524	ORIG	2021-12-10
69046	ORIG	2021-10-21
68811	ORIG	2021-09-30
68809	ORIG	2021-09-29