Details for New Drug Application (NDA): 022037

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NDA 022037 describes INTUNIV, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the INTUNIV profile page.

The generic ingredient in INTUNIV is guanfacine hydrochloride. There are seven drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the guanfacine hydrochloride profile page.

Summary for 022037

Tradename:	INTUNIV
Applicant:	Takeda Pharms Usa
Ingredient:	guanfacine hydrochloride
Patents:	0

Pharmacology for NDA: 022037

Mechanism of Action	Adrenergic alpha2-Agonists

Medical Subject Heading (MeSH) Categories for 022037

Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents

Suppliers and Packaging for NDA: 022037

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037	NDA	Takeda Pharmaceuticals America, Inc.	54092-513	54092-513-02	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-513-02)
INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037	NDA	Takeda Pharmaceuticals America, Inc.	54092-515	54092-515-02	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-515-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 1MG BASE
Approval Date:	Sep 2, 2009	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 2MG BASE
Approval Date:	Sep 2, 2009	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 3MG BASE
Approval Date:	Sep 2, 2009	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022037

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	Sep 2, 2009	5,854,290*PED	⤷ Get Started Free
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009	6,811,794*PED	⤷ Get Started Free
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009	5,854,290*PED	⤷ Get Started Free
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	Sep 2, 2009	6,287,599*PED	⤷ Get Started Free
Takeda Pharms Usa	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	Sep 2, 2009	6,811,794*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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