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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Fuji
Baxter
Express Scripts
Johnson and Johnson
QuintilesIMS
Queensland Health
Deloitte
Chinese Patent Office

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020808

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NDA 020808 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 020808
Tradename:VISIPAQUE 320
Applicant:Ge Healthcare
Ingredient:iodixanol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020808
Mechanism of ActionX-Ray Contrast Activity
Suppliers and Packaging for NDA: 020808
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020808 NDA GE Healthcare Inc. 0407-2222 N 0407-2222-23
VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020808 NDA GE Healthcare Inc. 0407-2222 N 0407-2222-24

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength55%
Approval Date:Aug 29, 1997TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength65.2%
Approval Date:Aug 29, 1997TE:RLD:No
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 020808

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare VISIPAQUE 320 iodixanol INJECTABLE;INJECTION 020808-002 Aug 29, 1997 ➤ Sign Up ➤ Sign Up
Ge Healthcare VISIPAQUE 320 iodixanol INJECTABLE;INJECTION 020808-002 Aug 29, 1997 ➤ Sign Up ➤ Sign Up
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020808-001 Aug 29, 1997 ➤ Sign Up ➤ Sign Up
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020808-001 Aug 29, 1997 ➤ 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:

Merck
Medtronic
Express Scripts
Cerilliant
Deloitte
Daiichi Sankyo
Covington
Mallinckrodt
Accenture

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