Application 022192

Type: NDA
Sponsor: VANDA PHARMS INC

Related Records

Company: VANDA PHARMS INC

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FANAPT	ILOPERIDONE	TABLET;ORAL	1MG	Yes	Yes
002	FANAPT	ILOPERIDONE	TABLET;ORAL	2MG	Yes	No
003	FANAPT	ILOPERIDONE	TABLET;ORAL	4MG	Yes	No
004	FANAPT	ILOPERIDONE	TABLET;ORAL	6MG	Yes	No
005	FANAPT	ILOPERIDONE	TABLET;ORAL	8MG	Yes	No
006	FANAPT	ILOPERIDONE	TABLET;ORAL	10MG	Yes	No
007	FANAPT	ILOPERIDONE	TABLET;ORAL	12MG	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43068-101	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-101	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-102	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-102	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-104	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-104	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-106	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-106	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-108	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-108	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-110	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-110	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-112	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-112	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-113	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-113	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-901	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-901	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-902	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-902	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-903	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
43068-903	Fanapt	iloperidone	Vanda Pharmaceuticals Inc.	NDA	Current
69189-0597	FANAPT	Iloperidone	Avera McKennan Hospital	NDA	Current
69189-0665	Fanapt	iloperidone	Avera McKennan Hospital	NDA	Current
70518-1867	Fanapt	iloperidone	REMEDYREPACK INC.	NDA	Current

Documents

Document	Submission type	Date
81116	SUPPL	2025-02-06
81002	SUPPL	2025-02-05
78110	SUPPL	2024-04-18
78050	SUPPL	2024-04-03
47403	SUPPL	2017-03-02
47402	SUPPL	2017-03-02
47311	SUPPL	2017-02-24
47310	SUPPL	2017-02-24
17063	SUPPL	2016-06-01
29384	SUPPL	2016-05-27
17064	SUPPL	2016-01-06
7022	SUPPL	2016-01-06
38364	SUPPL	2014-04-22
29383	SUPPL	2014-04-22
7020	SUPPL	2013-02-04
38362	SUPPL	2013-02-01
7021	SUPPL	2012-01-31
38363	SUPPL	2012-01-30
23701	ORIG	2011-12-22
38361	SUPPL	2011-09-12
17062	SUPPL	2011-09-12
7019	SUPPL	2011-09-12
7018	SUPPL	2011-09-12
17061	SUPPL	2011-03-28
7017	SUPPL	2011-03-24
29382	SUPPL	2010-12-06
38360	SUPPL	2010-12-04
38359	SUPPL	2010-08-27
29381	SUPPL	2010-08-26
24254	ORIG	2009-06-12
21955	ORIG	2009-06-12
17060	ORIG	2009-05-11
7016	ORIG	2009-05-11