Details for New Drug Application (NDA): 022205

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NDA 022205 describes GIAZO, which is a drug marketed by Valeant Pharms Intl and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the GIAZO profile page.

The generic ingredient in GIAZO is balsalazide disodium. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.

Summary for 022205

Tradename:	GIAZO
Applicant:	Valeant Pharms Intl
Ingredient:	balsalazide disodium
Patents:	4

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 3, 2012	TE:		RLD:	Yes
Patent:	7,452,872	Patent Expiration:	Aug 24, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
Patent:	7,625,884	Patent Expiration:	Aug 24, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
Patent:	8,497,256	Patent Expiration:	Jun 23, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS

Expired US Patents for NDA 022205

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012	6,197,341	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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