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Last Updated: January 22, 2020

DrugPatentWatch Database Preview

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. It is available from one supplier. 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. Seven 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
Pharmacology for NDA: 022205
Suppliers and Packaging for NDA: 022205
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GIAZO balsalazide disodium TABLET;ORAL 022205 NDA Salix Pharmaceuticals, Inc 65649-102 65649-102-02 180 TABLET, FILM COATED in 1 BOTTLE (65649-102-02)
Paragraph IV (Patent) Challenges for 022205
Tradename Dosage Ingredient NDA Submissiondate
GIAZO TABLET;ORAL balsalazide disodium 022205 2013-11-05

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1.1GM
Approval Date:Feb 3, 2012TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 24, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
Patent:  Start TrialPatent Expiration:Aug 24, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
Patent:  Start TrialPatent Expiration:Jun 23, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS

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