NDA 18956, held by Ge Healthcare. Iohexol.
As of Nov 13, 2026, NDA 18956 (Omnipaque 180, Omnipaque 240, Omnipaque 300), held by Ge Healthcare, was first approved by FDA on Dec 26, 1985, with 67 approved supplements and 0 published complete response letters.
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.
| Jul 13, 1993 | Supplement 28Efficacy (new indication or use) | Approved | |
| Nov 30, 1989 | Supplement 26Efficacy (new indication or use) | Approved | None posted |
| Jul 28, 1989 | Supplement 23Efficacy (new indication or use) | Approved | None posted |
| Jul 28, 1989 | Supplement 22Efficacy (new indication or use) | Approved | None posted |
| Jun 30, 1989 | Supplement 21Efficacy (new indication or use) | Approved | None posted |
| Jun 30, 1989 | Supplement 20Efficacy (new indication or use) | Approved | None posted |
| Mar 31, 1989 | Supplement 18Efficacy (new indication or use) | Approved | None posted |
| Nov 30, 1988 | Supplement 17Efficacy (new indication or use) | Approved | None posted |
| Jul 29, 1988 | Supplement 14Efficacy (new indication or use) | Approved | None posted |
| May 24, 1988 | Supplement 15Efficacy (new indication or use) | Approved | None posted |
| Feb 1, 1988 | Supplement 12Efficacy (new indication or use) | Approved | None posted |
| May 12, 1987 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Nov 26, 1986 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Dec 26, 1985 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Omnipaque 18038.8% · solution;injection, oral, rectal | Iohexol | RxReference drug |
| Omnipaque 24051.8% · solution;injection, oral, rectal | Iohexol | RxReference drug |
| Omnipaque 30064.7% · solution;injection, oral, rectal | Iohexol | RxReference drug |
| Omnipaque 35075.5% · solution;injection, oral | Iohexol | RxReference drug |
| Omnipaque 14030.2% · injectable;injection | Iohexol | RxReference drug |
| Omnipaque 21045.3% · injectable;injection | Iohexol | Discontinued |
| Omnipaque 7015.1% · solution;urethral | Iohexol | Discontinued |
| Omnipaque 91.9% · solution;oral | Iohexol | RxReference drug |
| Omnipaque 122.6% · solution;oral | Iohexol | RxReference drug |
| Oct 8, 2024 | Supplement 119Labeling · Standard review | Approved | |
| Apr 25, 2023 | Supplement 116Labeling · Standard review | Approved | |
| Feb 18, 2022 | Supplement 113Labeling · Standard review | Approved | |
| Aug 5, 2021 | Supplement 112Labeling · Standard review | Approved | |
| Nov 4, 2020 | Supplement 108Labeling · Standard review | Approved | |
| Jul 2, 2020 | Supplement 105Labeling · Standard review | Approved | |
| Apr 17, 2018 | Supplement 101Labeling · Standard review | Approved | |
| Apr 5, 2017 | Supplement 99Labeling · Standard review | Approved | |
| Oct 21, 2015 | Supplement 96Manufacturing · Standard review | Approved | None posted |
| Jul 6, 2015 | Supplement 95Labeling · Standard review | Approved | |
| Mar 3, 2015 | Supplement 94Manufacturing · Standard review | Approved | None posted |
| Jun 19, 2014 | Supplement 93Manufacturing · Standard review | Approved | None posted |
| Feb 10, 2014 | Supplement 91Manufacturing · Standard review | Approved | None posted |
| Nov 20, 2013 | Supplement 92Manufacturing · Standard review | Approved | None posted |
| Aug 21, 2013 | Supplement 89Manufacturing · Standard review | Approved | None posted |
| Oct 1, 2007 | Supplement 76Labeling · Standard review | Approved | |
| Mar 25, 2005 | Supplement 65Manufacturing · Standard review | Approved | |
| Dec 27, 2004 | Supplement 62Labeling · Standard review | Approved | |
| Mar 5, 2004 | Supplement 58Labeling · Standard review | Approved | |
| Dec 23, 2002 | Supplement 39Labeling | Approved | |
| Dec 23, 2002 | Supplement 49Labeling · Standard review | Approved | |
| Nov 20, 2002 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Aug 5, 2002 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Dec 19, 2000 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Sep 8, 1998 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Dec 4, 1995 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1995 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Jun 15, 1995 | Supplement 43Labeling · Standard review | Approved | |
| Nov 4, 1994 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1994 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Jun 1, 1994 | Supplement 36Labeling | Approved | None posted |
| Jun 1, 1994 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Dec 23, 1993 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 13, 1993 | Supplement 28Efficacy (new indication or use) | Approved | |
| Mar 1, 1993 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1993 | Supplement 33Labeling | Approved | None posted |
| Mar 1, 1993 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1993 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Dec 11, 1992 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Oct 20, 1992 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1992 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1992 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1990 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1989 | Supplement 26Efficacy (new indication or use) | Approved | None posted |
| Jul 28, 1989 | Supplement 23Efficacy (new indication or use) | Approved | None posted |
| Jul 28, 1989 | Supplement 22Efficacy (new indication or use) | Approved | None posted |
| Jun 30, 1989 | Supplement 21Efficacy (new indication or use) | Approved | None posted |
| Jun 30, 1989 | Supplement 20Efficacy (new indication or use) | Approved | None posted |
| May 22, 1989 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 3, 1989 | Supplement 24Labeling | Approved | None posted |
| Mar 31, 1989 | Supplement 18Efficacy (new indication or use) | Approved | None posted |
| Jan 4, 1989 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1988 | Supplement 17Efficacy (new indication or use) | Approved | None posted |
| Jul 29, 1988 | Supplement 14Efficacy (new indication or use) | Approved | None posted |
| May 24, 1988 | Supplement 15Efficacy (new indication or use) | Approved | None posted |
| Apr 18, 1988 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1988 | Supplement 12Efficacy (new indication or use) | Approved | None posted |
| Jan 27, 1988 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 4, 1987 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 27, 1987 | Supplement 6Labeling | Approved | None posted |
| May 12, 1987 | Supplement 9Efficacy (new indication or use) | Approved | None posted |
| Apr 21, 1987 | Supplement 4Labeling | Approved | None posted |
| Feb 5, 1987 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Nov 20, 1986 | Supplement 3Labeling | Approved | None posted |
| Dec 26, 1985 | Original applicationNew molecular entity · Standard review | Approved | None posted |
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
