Application 207202

Type: NDA
Sponsor: OTSUKA PHARM CO LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceut	NDA	Current
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceut	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceut	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceut	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceut	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceut	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81138	SUPPL	2025-02-07
81020	SUPPL	2025-02-05
81019	SUPPL	2025-02-05
72782	SUPPL	2022-12-05
72781	SUPPL	2022-12-05
72757	SUPPL	2022-12-01
65741	SUPPL	2020-12-28
65740	SUPPL	2020-12-28
61815	SUPPL	2020-02-06
61813	SUPPL	2020-02-06
61812	SUPPL	2020-02-06
61811	SUPPL	2020-02-06
61795	SUPPL	2020-02-06
61794	SUPPL	2020-02-06
55134	ORIG	2018-08-08
50415	ORIG	2017-11-15
50398	ORIG	2017-11-13

Application 207202

Related Records#

Application Products#

NDC Listings For This Application#

Documents#