Details for New Drug Application (NDA): 021436

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NDA 021436 describes ABILIFY, which is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in seven NDAs. It is available from one supplier. There are forty-six patents protecting this drug and three Paragraph IV challenges. Additional details are available on the ABILIFY profile page.

The generic ingredient in ABILIFY 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 021436

Tradename:	ABILIFY
Applicant:	Otsuka
Ingredient:	aripiprazole
Patents:	3

Pharmacology for NDA: 021436

Medical Subject Heading (MeSH) Categories for 021436

Antipsychotic Agents

Suppliers and Packaging for NDA: 021436

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABILIFY	aripiprazole	TABLET;ORAL	021436	NDA	Otsuka America Pharmaceutical, Inc.	59148-006	59148-006-13	30 TABLET in 1 BOTTLE, PLASTIC (59148-006-13)
ABILIFY	aripiprazole	TABLET;ORAL	021436	NDA	Otsuka America Pharmaceutical, Inc.	59148-006	59148-006-92	7 TABLET in 1 BLISTER PACK (59148-006-92)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 15, 2002	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Dec 16, 2024	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Mar 2, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Patent:	⤷ Sign Up	Patent Expiration:	Jul 28, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER

Expired US Patents for NDA 021436

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-004	Nov 15, 2002	⤷ Sign Up	⤷ Sign Up
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-002	Nov 15, 2002	⤷ Sign Up	⤷ Sign Up
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-003	Nov 15, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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