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Last Updated: April 24, 2024

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. Ten 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:DISCNDosage:TABLET;ORALStrength1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 3, 2012TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Aug 24, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
Patent:⤷  Try a TrialPatent Expiration:Aug 24, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
Patent:⤷  Try a 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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