Details for New Drug Application (NDA): 022363

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NDA 022363 describes LIVALO, which is a drug marketed by Kowa Co and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LIVALO profile page.

The generic ingredient in LIVALO is pitavastatin calcium. There are fifteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the pitavastatin calcium profile page.

Summary for 022363

Tradename:	LIVALO
Applicant:	Kowa Co
Ingredient:	pitavastatin calcium
Patents:	2

Pharmacology for NDA: 022363

Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Suppliers and Packaging for NDA: 022363

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIVALO	pitavastatin calcium	TABLET;ORAL	022363	NDA	Kowa Pharmaceuticals America, Inc.	66869-104	66869-104-90	90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-104-90)
LIVALO	pitavastatin calcium	TABLET;ORAL	022363	NDA	Kowa Pharmaceuticals America, Inc.	66869-204	66869-204-90	90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-204-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Aug 3, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 19, 2024	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Aug 2, 2024	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE
Approval Date:	Aug 3, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 19, 2024	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022363

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	⤷ Sign Up	⤷ Sign Up
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	⤷ Sign Up	⤷ Sign Up
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	⤷ Sign Up	⤷ Sign Up
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	⤷ Sign Up	⤷ Sign Up
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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