Application 202971

Type: NDA
Sponsor: OTSUKA PHARM CO LTD

Related Records

Company: OTSUKA PHARM CO LTD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	300MG/VIAL	Yes	No
002	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	400MG/VIAL	Yes	Yes
003	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	300MG	Yes	No
004	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	400MG	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59148-018	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-018	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-018	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-018	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-018	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-019	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-019	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-019	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-019	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-019	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-045	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-045	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-045	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-045	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-045	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-072	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-072	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-072	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-072	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-072	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current

Documents

Document	Submission type	Date
81815	SUPPL	2026-03-02
84874	SUPPL	2026-01-29
84873	SUPPL	2026-01-29
82920	SUPPL	2025-07-25
82917	SUPPL	2025-07-24
81892	SUPPL	2025-04-09
81816	SUPPL	2025-04-03
81134	SUPPL	2025-02-07
80944	SUPPL	2025-02-05
61808	SUPPL	2020-02-06
61793	SUPPL	2020-02-06
61807	SUPPL	2020-02-05
49289	SUPPL	2017-08-08
49180	SUPPL	2017-08-02
49150	SUPPL	2017-07-31
47428	SUPPL	2017-03-02
47323	SUPPL	2017-02-24
45101	SUPPL	2016-08-23
45146	SUPPL	2016-08-18
19404	SUPPL	2016-01-22
10140	SUPPL	2016-01-20
40245	SUPPL	2015-07-30
32344	SUPPL	2015-07-30
43418	SUPPL	2015-07-27
19403	SUPPL	2014-12-10
10139	SUPPL	2014-12-09
40244	SUPPL	2014-09-30
40243	SUPPL	2014-06-03
44872	ORIG	2013-04-11
22904	ORIG	2013-04-11
19402	ORIG	2013-03-15
10138	ORIG	2013-03-01