Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Federal Trade Commission
Merck
US Department of Justice
UBS
Farmers Insurance
Queensland Health
Dow
QuintilesIMS

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020608

« Back to Dashboard

NDA 020608 describes OMNIPAQUE 300, which is a drug marketed by Ge Healthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the OMNIPAQUE 300 profile page.

The generic ingredient in OMNIPAQUE 300 is iohexol. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iohexol profile page.
Summary for 020608
Tradename:OMNIPAQUE 300
Applicant:Ge Healthcare
Ingredient:iohexol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020608
Mechanism of ActionX-Ray Contrast Activity
Medical Subject Heading (MeSH) Categories for 020608
Suppliers and Packaging for NDA: 020608
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMNIPAQUE 350 iohexol SOLUTION;INJECTION, ORAL 020608 NDA GE Healthcare 0407-1413 N 0407-1413-48
OMNIPAQUE 350 iohexol SOLUTION;INJECTION, ORAL 020608 NDA GE Healthcare 0407-1413 N 0407-1413-72

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTION, ORAL, RECTALStrength51.8%
Approval Date:Oct 24, 1995TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTION, ORAL, RECTALStrength64.7%
Approval Date:Oct 24, 1995TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTION, ORALStrength75.5%
Approval Date:Oct 24, 1995TE:RLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Deloitte
Merck
Chubb
Mallinckrodt
Daiichi Sankyo
Accenture
Federal Trade Commission
Fish and Richardson

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.