Details for New Drug Application (NDA): 217006

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NDA 217006 describes ABILIFY ASIMTUFII, which is a drug marketed by Otsuka and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ABILIFY ASIMTUFII profile page.

The generic ingredient in ABILIFY ASIMTUFII 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 217006

Tradename:	ABILIFY ASIMTUFII
Applicant:	Otsuka
Ingredient:	aripiprazole
Patents:	6

Pharmacology for NDA: 217006

Medical Subject Heading (MeSH) Categories for 217006

Antipsychotic Agents

Suppliers and Packaging for NDA: 217006

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006	NDA	Otsuka America Pharmaceutical, Inc	59148-102	59148-102-80	1 SYRINGE in 1 CARTON (59148-102-80) / 2.4 mL in 1 SYRINGE
ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006	NDA	Otsuka America Pharmaceutical, Inc	59148-114	59148-114-80	1 SYRINGE in 1 CARTON (59148-114-80) / 3.2 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR			Strength	720MG/2.4ML (300MG/ML)
Approval Date:	Apr 27, 2023	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Apr 23, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
Patent:	⤷ Sign Up	Patent Expiration:	Apr 23, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF SCHIZOPHRENIA
Patent:	⤷ Sign Up	Patent Expiration:	Apr 23, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER

Expired US Patents for NDA 217006

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023	⤷ Sign Up	⤷ Sign Up
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023	⤷ Sign Up	⤷ Sign Up
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023	⤷ Sign Up	⤷ Sign Up
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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