Details for New Drug Application (NDA): 207202

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NDA 207202 describes ABILIFY MYCITE KIT, which is a drug marketed by Otsuka and is included in one NDA. It is available from one supplier. There are twenty-eight patents protecting this drug. Additional details are available on the ABILIFY MYCITE KIT profile page.

The generic ingredient in ABILIFY MYCITE KIT is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

Summary for 207202

Tradename:	ABILIFY MYCITE KIT
Applicant:	Otsuka
Ingredient:	aripiprazole
Patents:	28

Pharmacology for NDA: 207202

Medical Subject Heading (MeSH) Categories for 207202

Antipsychotic Agents

Suppliers and Packaging for NDA: 207202

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202	NDA	Otsuka America Pharmaceutical, Inc.	59148-029	59148-029-61	1 BOTTLE in 1 KIT (59148-029-61) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-029-13)
ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202	NDA	Otsuka America Pharmaceutical, Inc.	59148-029	59148-029-72	1 BOTTLE in 1 KIT (59148-029-72) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-029-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Nov 13, 2017	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 26, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jun 13, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jul 11, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 207202

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-001	Nov 13, 2017	⤷ Sign Up	⤷ Sign Up
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-006	Nov 13, 2017	⤷ Sign Up	⤷ Sign Up
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017	⤷ Sign Up	⤷ Sign Up
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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