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Last Updated: July 2, 2020

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Details for New Drug Application (NDA): 020608


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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 Inc. 0407-1413 0407-1413-68 10 BOTTLE, PLASTIC in 1 BOX (0407-1413-68) > 500 mL in 1 BOTTLE, PLASTIC
OMNIPAQUE 350 iohexol SOLUTION;INJECTION, ORAL 020608 NDA GE Healthcare Inc. 0407-1413 0407-1413-72 10 BOTTLE, PLASTIC in 1 BOX (0407-1413-72) > 500 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage: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

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