Application 203858

Type: NDA
Sponsor: AEGERION

Related Records

Company: AEGERION

Application Products

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

NDC Listings For This Application

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