Details for New Drug Application (NDA): 022465

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NDA 022465 describes VOTRIENT, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the VOTRIENT profile page.

The generic ingredient in VOTRIENT is pazopanib hydrochloride. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the pazopanib hydrochloride profile page.

Summary for 022465

Tradename:	VOTRIENT
Applicant:	Novartis
Ingredient:	pazopanib hydrochloride
Patents:	0

Pharmacology for NDA: 022465

Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

Suppliers and Packaging for NDA: 022465

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465	NDA	Novartis Pharmaceuticals Corporation	0078-1077	0078-1077-66	120 TABLET, FILM COATED in 1 BOTTLE (0078-1077-66)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 200MG BASE
Approval Date:	Oct 19, 2009	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 19, 2009	TE:		RLD:	Yes

Expired US Patents for NDA 022465

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-001	Oct 19, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-001	Oct 19, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-001	Oct 19, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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