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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Boehringer Ingelheim
US Army
Moodys
Daiichi Sankyo
Julphar
Federal Trade Commission
UBS
AstraZeneca

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020351

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NDA 020351 describes VISIPAQUE 320, which is a drug marketed by Ge Healthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the VISIPAQUE 320 profile page.

The generic ingredient in VISIPAQUE 320 is iodixanol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the iodixanol profile page.
Summary for 020351
Tradename:VISIPAQUE 320
Applicant:Ge Healthcare
Ingredient:iodixanol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020351
Mechanism of ActionX-Ray Contrast Activity
Suppliers and Packaging for NDA: 020351
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020351 NDA GE Healthcare Inc. 0407-2222 N 0407-2222-23
VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020351 NDA GE Healthcare Inc. 0407-2222 N 0407-2222-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength55%
Approval Date:Mar 22, 1996TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength65.2%
Approval Date:Mar 22, 1996TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 5, 2020
Regulatory Exclusivity Use:CORONARY COMPUTED TOMOGRAPHY ANGIOGRAPHY (CCTA) TO ASSIST DIAGNOSTIC EVALUATION OF PATIENTS WITH SUSPECTED CORONARY ARTERY DISEASE

Expired US Patents for NDA 020351

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020351-001 Mar 22, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020351-001 Mar 22, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020351-001 Mar 22, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020351-001 Mar 22, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Chinese Patent Office
Cipla
Farmers Insurance
Moodys
US Department of Justice
Chubb
Colorcon
Accenture

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