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Generated: November 14, 2018

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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 0407-2222-23 10 BOTTLE, PLASTIC in 1 BOX (0407-2222-23) > 500 mL in 1 BOTTLE, PLASTIC
VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020351 NDA GE Healthcare Inc. 0407-2222 0407-2222-24 10 BOTTLE, PLASTIC in 1 BOX (0407-2222-24) > 500 mL in 1 BOTTLE, PLASTIC

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 320 iodixanol INJECTABLE;INJECTION 020351-002 Mar 22, 1996 ➤ Sign Up ➤ Sign Up
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020351-001 Mar 22, 1996 ➤ Sign Up ➤ Sign Up
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020351-001 Mar 22, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Chubb
Baxter
Fish and Richardson
Accenture
Covington
Mallinckrodt
QuintilesIMS
Citi

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