Application 203858

Type: NDA
Sponsor: AEGERION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JUXTAPID	LOMITAPIDE MESYLATE	CAPSULE;ORAL	EQ 5MG BASE	Yes	No
002	JUXTAPID	LOMITAPIDE MESYLATE	CAPSULE;ORAL	EQ 10MG BASE	Yes	No
003	JUXTAPID	LOMITAPIDE MESYLATE	CAPSULE;ORAL	EQ 20MG BASE	Yes	No
004	JUXTAPID	LOMITAPIDE MESYLATE	CAPSULE;ORAL	EQ 30MG BASE	Yes	No
005	JUXTAPID	LOMITAPIDE MESYLATE	CAPSULE;ORAL	EQ 40MG BASE	Yes	No
006	JUXTAPID	LOMITAPIDE MESYLATE	CAPSULE;ORAL	EQ 60MG BASE	Yes	Yes
007	JUXTAPID	LOMITAPIDE MESYLATE	CAPSULE;ORAL	EQ 2MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N203858-001	JUXTAPID	LOMITAPIDE MESYLATE	EQ 5MG BASE	CAPSULE / ORAL	RLD	2012-12-21
N203858-002	JUXTAPID	LOMITAPIDE MESYLATE	EQ 10MG BASE	CAPSULE / ORAL	RLD	2012-12-21
N203858-003	JUXTAPID	LOMITAPIDE MESYLATE	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-12-21
N203858-004	JUXTAPID	LOMITAPIDE MESYLATE	EQ 30MG BASE	CAPSULE / ORAL	RLD, RS	2015-04-23
N203858-005	JUXTAPID	LOMITAPIDE MESYLATE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2015-04-23
N203858-006	JUXTAPID	LOMITAPIDE MESYLATE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2015-04-23
N203858-007	JUXTAPID	LOMITAPIDE MESYLATE	EQ 2MG BASE	CAPSULE / ORAL	RLD	2026-02-25

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N203858-001	7932268	2027-08-19	U-1316	2013-01-14
N203858-001	12472172	2041-07-29	U-4438	2026-03-25
N203858-002	7932268	2027-08-19	U-1316
N203858-002	12472172	2041-07-29	U-4438	2026-03-25
N203858-003	7932268	2027-08-19	U-1316
N203858-003	12472172	2041-07-29	U-4438	2026-03-25
N203858-004	7932268	2027-08-19	U-1316	2015-05-29
N203858-004	12472172	2041-07-29	U-4438	2026-03-25
N203858-005	7932268	2027-08-19	U-1316	2015-05-29
N203858-006	7932268	2027-08-19	U-1316	2015-05-29
N203858-007	7932268	2027-08-19	U-1316	2026-03-27
N203858-007	12472172	2041-07-29	U-4438	2026-03-25

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N203858-001	NPP	2029-02-25
N203858-002	NPP	2029-02-25
N203858-003	NPP	2029-02-25
N203858-004	NPP	2029-02-25
N203858-005	NPP	2029-02-25
N203858-007	NS	2029-02-25

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 7 · 254 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203858-001	JUXTAPID	EQ 5MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-002	JUXTAPID	EQ 10MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-003	JUXTAPID	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-004	JUXTAPID	EQ 30MG BASE	CAPSULE / ORAL	RLD, RS	2015-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-005	JUXTAPID	EQ 40MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-006	JUXTAPID	EQ 60MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-007	JUXTAPID	EQ 2MG BASE	CAPSULE / ORAL	RLD	2026-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203858-001	JUXTAPID	EQ 5MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203858-002	JUXTAPID	EQ 10MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203858-003	JUXTAPID	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203858-004	JUXTAPID	EQ 30MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203858-005	JUXTAPID	EQ 40MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203858-006	JUXTAPID	EQ 60MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-001	JUXTAPID	EQ 5MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-002	JUXTAPID	EQ 10MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-003	JUXTAPID	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-004	JUXTAPID	EQ 30MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-005	JUXTAPID	EQ 40MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-006	JUXTAPID	EQ 60MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203858-001	JUXTAPID	EQ 5MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203858-002	JUXTAPID	EQ 10MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203858-003	JUXTAPID	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203858-004	JUXTAPID	EQ 30MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203858-005	JUXTAPID	EQ 40MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203858-006	JUXTAPID	EQ 60MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203858-001	JUXTAPID	EQ 5MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203858-002	JUXTAPID	EQ 10MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203858-003	JUXTAPID	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203858-004	JUXTAPID	EQ 30MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203858-005	JUXTAPID	EQ 40MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203858-006	JUXTAPID	EQ 60MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203858-001	JUXTAPID	EQ 5MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203858-002	JUXTAPID	EQ 10MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203858-003	JUXTAPID	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203858-004	JUXTAPID	EQ 30MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203858-005	JUXTAPID	EQ 40MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203858-006	JUXTAPID	EQ 60MG BASE	CAPSULE / ORAL	RLD	2015-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203858-001	JUXTAPID	EQ 5MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203858-002	JUXTAPID	EQ 10MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203858-003	JUXTAPID	EQ 20MG BASE	CAPSULE / ORAL	RLD	2012-12-21	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 49 · 1,938 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203858-001	7932268	2027-08-19	U-1316	2013-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-001	12472172	2041-07-29	U-4438	2026-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-002	7932268	2027-08-19	U-1316		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-002	12472172	2041-07-29	U-4438	2026-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-003	7932268	2027-08-19	U-1316		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-003	12472172	2041-07-29	U-4438	2026-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-004	7932268	2027-08-19	U-1316	2015-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-004	12472172	2041-07-29	U-4438	2026-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-005	7932268	2027-08-19	U-1316	2015-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-006	7932268	2027-08-19	U-1316	2015-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-007	7932268	2027-08-19	U-1316	2026-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-007	12472172	2041-07-29	U-4438	2026-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203858-001	7932268	2027-08-19	U-1316	2013-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203858-002	7932268	2027-08-19	U-1316		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203858-003	7932268	2027-08-19	U-1316		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203858-004	7932268	2027-08-19	U-1316	2015-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203858-005	7932268	2027-08-19	U-1316	2015-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203858-006	7932268	2027-08-19	U-1316	2015-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-001	10016404	2025-03-07	U-1316	2018-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-001	10555938	2025-03-07	U-1316	2020-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-001	8618135	2025-03-07	U-1316	2014-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-001	9265758	2025-03-07	U-1316	2016-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-001	9364470	2025-03-07	U-1851	2016-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-001	9433617	2025-03-07	U-1316	2016-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-001	9861622	2025-03-07	U-1316	2018-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-001	7932268	2027-08-19	U-1316	2013-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-002	10016404	2025-03-07	U-1316	2018-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-002	10555938	2025-03-07	U-1316	2020-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-002	8618135	2025-03-07	U-1316	2014-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-002	9265758	2025-03-07	U-1316	2016-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-002	9364470	2025-03-07	U-1851	2016-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-002	9433617	2025-03-07	U-1316	2016-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-002	9861622	2025-03-07	U-1316	2018-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-002	7932268	2027-08-19	U-1316		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-003	10016404	2025-03-07	U-1316	2018-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-003	10555938	2025-03-07	U-1316	2020-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-003	8618135	2025-03-07	U-1316	2014-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-003	9265758	2025-03-07	U-1316	2016-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-003	9364470	2025-03-07	U-1851	2016-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203858-003	9433617	2025-03-07	U-1316	2016-09-08	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N203858-001	NPP	2029-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-002	NPP	2029-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-003	NPP	2029-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-004	NPP	2029-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-005	NPP	2029-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203858-007	NS	2029-02-25	`caaa826d4ba7…`
2019-12-13 00:20 UTC	2019-12	N203858-001	ODE-36	2019-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203858-002	ODE-36	2019-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203858-003	ODE-36	2019-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203858-004	ODE-36	2019-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203858-005	ODE-36	2019-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203858-006	ODE-36	2019-12-21	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N203858-001	ODE-36	2019-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203858-002	ODE-36	2019-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203858-003	ODE-36	2019-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203858-004	ODE-36	2019-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203858-005	ODE-36	2019-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203858-006	ODE-36	2019-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203858-001	ODE-36	2019-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203858-002	ODE-36	2019-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203858-003	ODE-36	2019-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203858-004	ODE-36	2019-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203858-005	ODE-36	2019-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203858-006	ODE-36	2019-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203858-001	ODE-36	2019-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203858-002	ODE-36	2019-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203858-003	ODE-36	2019-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203858-004	ODE-36	2019-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203858-005	ODE-36	2019-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203858-006	ODE-36	2019-12-21	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203858-001	NPP	2029-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203858-002	NPP	2029-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203858-003	NPP	2029-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203858-004	NPP	2029-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203858-005	NPP	2029-02-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203858-007	NS	2029-02-25	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Juxtapid	LOMITAPIDE MESYLATE	Chiesi USA, Inc.	61a0be9d-ee58-43e0-b5cb-141011835081	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203858 application number: NDA203858
Juxtapid	LOMITAPIDE MESYLATE	Amryt Pharmaceuticals DAC	e4c45bb5-15f4-437e-ab98-a649b3676d14	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203858 application number: NDA203858 ndc (product): 76431-130 ndc (product): 76431-105 ndc (product): 76431-120 ndc (product): 76431-110

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
76431-105	Juxtapid	lomitapide mesylate	Amryt Pharmaceutcials DAC	NDA	Current
76431-105	Juxtapid	lomitapide mesylate	Amryt Pharmaceutcials DAC	NDA	Current
76431-105	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-105	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-105	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-105	Juxtapid	lomitapide mesylate	Amryt Pharmaceuticals DAC	NDA	Current
76431-110	Juxtapid	lomitapide mesylate	Amryt Pharmaceutcials DAC	NDA	Current
76431-110	Juxtapid	lomitapide mesylate	Amryt Pharmaceutcials DAC	NDA	Current
76431-110	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-110	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-110	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-110	Juxtapid	lomitapide mesylate	Amryt Pharmaceuticals DAC	NDA	Current
76431-120	Juxtapid	lomitapide mesylate	Amryt Pharmaceutcials DAC	NDA	Current
76431-120	Juxtapid	lomitapide mesylate	Amryt Pharmaceutcials DAC	NDA	Current
76431-120	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-120	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-120	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-120	Juxtapid	lomitapide mesylate	Amryt Pharmaceuticals DAC	NDA	Current
76431-130	Juxtapid	lomitapide mesylate	Amryt Pharmaceutcials DAC	NDA	Current
76431-130	Juxtapid	lomitapide mesylate	Amryt Pharmaceutcials DAC	NDA	Current
76431-130	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-130	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-130	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-130	Juxtapid	lomitapide mesylate	Amryt Pharmaceuticals DAC	NDA	Current
76431-140	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-140	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-140	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-160	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-160	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current
76431-160	Juxtapid	lomitapide mesylate	Aegerion Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85174	SUPPL	2026-03-02
85175	SUPPL	2026-02-27
71488	SUPPL	2022-06-30
71350	SUPPL	2022-06-17
70045	SUPPL	2022-02-02
67626	SUPPL	2021-05-28
61444	SUPPL	2019-12-26
61419	SUPPL	2019-12-23
54456	SUPPL	2018-06-05
49241	SUPPL	2017-08-04
49229	SUPPL	2017-08-04
49164	SUPPL	2017-07-31
46673	SUPPL	2017-01-05
46672	SUPPL	2017-01-05
32476	SUPPL	2016-05-25
19501	SUPPL	2016-05-25
40330	SUPPL	2016-03-14
32475	SUPPL	2016-03-10
19500	SUPPL	2015-04-24
10258	SUPPL	2015-04-24
19499	SUPPL	2014-08-12
10257	SUPPL	2014-08-11
19498	SUPPL	2014-02-19
10256	SUPPL	2014-02-19
10255	SUPPL	2013-08-15
32474	SUPPL	2013-04-16
19497	SUPPL	2013-04-16
22936	ORIG	2013-02-11
19496	ORIG	2012-12-31
44590	ORIG	2012-12-28
32473	ORIG	2012-12-27