Omnipaque 240, Omnipaque 300, Omnipaque 350

NDA 20608, held by Ge Healthcare. Iohexol.

As of Nov 13, 2026, NDA 20608 (Omnipaque 240, Omnipaque 300, Omnipaque 350), held by Ge Healthcare, was first approved by FDA on Oct 24, 1995, with 16 approved supplements and 0 published complete response letters.

First approved: Oct 24, 1995
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. 1.1 Intrathecal Procedures ‡ OMNIPAQUE is indicated for: Myelography and computerized tomography (CT) myelography (lumbar, thoracic, cervical, total columnar) in adults and pediatric patients aged 2 weeks and older CT cisternography in adults and pediatric patients aged 2 weeks and older 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Oct 24, 1995	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Omnipaque 24051.8% · solution;injection, oral, rectal	Iohexol	Discontinued
Omnipaque 30064.7% · solution;injection, oral, rectal	Iohexol	Rx
Omnipaque 35075.5% · solution;injection, oral	Iohexol	Rx

All 17 submissions, including labeling and manufacturing supplements


Oct 8, 2024	Supplement 47Labeling · Standard review	Approved	Letter Label
Apr 25, 2023	Supplement 49Labeling · Standard review	Approved	Letter Label
Feb 18, 2022	Supplement 45Labeling · Standard review	Approved	Label Letter
Nov 9, 2017	Supplement 38Labeling · Standard review	Approved	Label Letter
Apr 5, 2017	Supplement 36Labeling · Standard review	Approved	Label
Apr 5, 2017	Supplement 37Labeling · Standard review	Approved	Letter Label
Dec 21, 2016	Supplement 34Labeling · Standard review	Approved	Letter Label
Jul 6, 2015	Supplement 31Labeling · Standard review	Approved	Letter Label
Oct 1, 2007	Supplement 18Labeling · Standard review	Approved	Letter
Mar 5, 2004	Supplement 9Labeling · Standard review	Approved	Letter
Feb 13, 2004	Supplement 10Labeling · Standard review	Approved	Letter
Nov 20, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 5, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 19, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 10, 1998	Supplement 1Labeling · Standard review	Approved	None posted
Jun 4, 1997	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 24, 1995	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20608
Drugs@FDA: Overview at FDA
Company: GE Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters