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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 five 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. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the balsalazide disodium profile page.

Summary for NDA: 022205

Tradename:
GIAZO
Applicant:
Valeant Pharms Intl
Ingredient:
balsalazide disodium
Patents:5
Therapeutic Class:Inflammatory Bowel Disease Agents

Pharmacology for NDA: 022205

Ingredient-typeAminosalicylic Acids

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 65649-102-01 6 TABLET, FILM COATED in 1 BOTTLE (65649-102-01)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.1GM
Approval Date:Feb 3, 2012TE:ABRLD:Yes
Patent:6,197,341Patent Expiration:Mar 13, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
Patent:7,452,872Patent Expiration:Aug 24, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
Patent:7,625,884Patent Expiration:Aug 24, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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