Application 021436

Type: NDA
Sponsor: OTSUKA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABILIFY	ARIPIPRAZOLE	TABLET;ORAL	10MG	Yes	Yes
002	ABILIFY	ARIPIPRAZOLE	TABLET;ORAL	15MG	Yes	No
003	ABILIFY	ARIPIPRAZOLE	TABLET;ORAL	20MG	Yes	No
004	ABILIFY	ARIPIPRAZOLE	TABLET;ORAL	30MG	Yes	No
005	ABILIFY	ARIPIPRAZOLE	TABLET;ORAL	5MG	Yes	Yes
006	ABILIFY	ARIPIPRAZOLE	TABLET;ORAL	2MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-002	ABILIFY	ARIPIPRAZOLE	Rebel Distributors Corp.	NDA	Current
21695-003	ABILIFY	ARIPIPRAZOLE	Rebel Distributors Corp.	NDA	Current
21695-004	ABILIFY	ARIPIPRAZOLE	Rebel Distributors Corp.	NDA	Current
21695-005	ABILIFY	ARIPIPRAZOLE	Rebel Distributors Corp.	NDA	Current
43353-848	ABILIFY	ARIPIPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-849	ABILIFY	ARIPIPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-850	ABILIFY	ARIPIPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
52959-604	ABILIFY	ARIPIPRAZOLE	H.J. Harkins Company, Inc.	NDA	Current
55289-251	ABILIFY	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-251	ABILIFY	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-251	ABILIFY	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-251	ABILIFY	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-251	ABILIFY	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-251	ABILIFY	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, In	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
63629-3387	ABILIFY	ARIPIPRAZOLE	Bryant Ranch Prepack	NDA	Current
63629-3387	ABILIFY	ARIPIPRAZOLE	Bryant Ranch Prepack	NDA	Current
64725-0006	ABILIFY	ARIPIPRAZOLE	TYA Pharmaceuticals	NDA	Current
64725-0007	ABILIFY	ARIPIPRAZOLE	TYA Pharmaceuticals	NDA	Current
64725-0009	ABILIFY	ARIPIPRAZOLE	TYA Pharmaceuticals	NDA	Current
64725-8000	ABILIFY	ARIPIPRAZOLE	TYA Pharmaceuticals	NDA	Current
68151-4461	ABILIFY	ARIPIPRAZOLE	Carilion Materials Management	NDA	Current
68151-4982	ABILIFY	ARIPIPRAZOLE	Carilion Materials Management	NDA	Current
68151-5121	ABILIFY	ARIPIPRAZOLE	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81133	SUPPL	2025-02-07
81132	SUPPL	2025-02-07
81025	SUPPL	2025-02-05
81024	SUPPL	2025-02-05
81023	SUPPL	2025-02-05
72780	SUPPL	2022-12-05
72779	SUPPL	2022-12-05
72756	SUPPL	2022-12-01
61819	SUPPL	2020-02-06
61818	SUPPL	2020-02-06
61817	SUPPL	2020-02-06
61816	SUPPL	2020-02-06
61792	SUPPL	2020-02-06
61791	SUPPL	2020-02-06
59634	SUPPL	2019-08-08
59633	SUPPL	2019-08-08
59622	SUPPL	2019-08-08
47424	SUPPL	2017-03-02
47330	SUPPL	2017-02-24
45787	SUPPL	2016-11-02
45238	SUPPL	2016-08-18
45086	SUPPL	2016-08-18
21657	SUPPL	2016-07-28
21656	SUPPL	2016-04-20
15466	SUPPL	2016-01-22
27780	SUPPL	2016-01-20
36925	SUPPL	2014-12-15
27779	SUPPL	2014-12-15
27777	SUPPL	2014-07-11
42164	SUPPL	2014-06-16
15464	SUPPL	2014-06-10
15465	SUPPL	2013-08-09
21654	SUPPL	2013-08-06
27778	SUPPL	2013-08-05
21653	SUPPL	2013-05-10
42160	SUPPL	2012-03-14
27776	SUPPL	2012-02-27
36924	SUPPL	2012-02-24
42163	SUPPL	2012-01-27
42162	SUPPL	2012-01-27
42161	SUPPL	2012-01-27
44122	ORIG	2011-12-22
5371	SUPPL	2011-03-08
15463	SUPPL	2011-03-07
36921	SUPPL	2011-02-24
5369	SUPPL	2011-02-18
5370	SUPPL	2010-12-07
36923	SUPPL	2010-12-03
27775	SUPPL	2010-12-03
36922	SUPPL	2010-12-02
5368	SUPPL	2009-11-27
15462	SUPPL	2009-11-23
24197	SUPPL	2009-08-20
21655	SUPPL	2009-08-20
27774	SUPPL	2009-07-24
36920	SUPPL	2009-07-23
15461	SUPPL	2008-08-26
5367	SUPPL	2008-08-19
24200	SUPPL	2008-07-17
24199	SUPPL	2008-07-17
24198	SUPPL	2008-07-17
27773	SUPPL	2008-05-14
27772	SUPPL	2008-05-14
5364	SUPPL	2008-05-14
5366	SUPPL	2008-03-07
5365	SUPPL	2008-02-29
15460	SUPPL	2008-02-28
27771	SUPPL	2007-11-19
15459	SUPPL	2007-11-19
27770	SUPPL	2007-11-08
36919	SUPPL	2007-11-07
5363	SUPPL	2007-10-04
36918	SUPPL	2007-09-26
42159	SUPPL	2007-09-24
21652	SUPPL	2007-09-24
36916	SUPPL	2006-10-23
27769	SUPPL	2006-10-23
36917	SUPPL	2006-09-20
5362	SUPPL	2006-09-20
36915	SUPPL	2006-02-22
27768	SUPPL	2006-02-22
36914	SUPPL	2005-06-23
27766	SUPPL	2005-06-23
27767	SUPPL	2005-03-03
27765	SUPPL	2005-03-03
15458	SUPPL	2005-03-03
15456	SUPPL	2005-03-03
27764	SUPPL	2004-10-04
15455	SUPPL	2004-10-04
15457	SUPPL	2004-05-03
5361	SUPPL	2004-04-20
15454	SUPPL	2003-09-09
5360	SUPPL	2003-09-09
42158	ORIG	2003-03-07
51237	SUPPL	2003-02-11
51236	SUPPL	2003-02-11
36913	ORIG	2002-11-15
27763	ORIG	2002-11-15
63504	ORIG	1900-01-01
63502	SUPPL	1900-01-01

Application 021436

Related Records#

Application Products#

NDC Listings For This Application#

Documents#