NDA 20123, held by Ge Healthcare. Gadodiamide.
As of Nov 13, 2026, NDA 20123 (Omniscan), held by Ge Healthcare, was first approved by FDA on Jan 8, 1993, with 34 approved supplements and 0 published complete response letters.
OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space 1.1 CNS (Central Nervous System) OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 5, 1996 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | None posted |
| Feb 5, 1996 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | None posted |
| Feb 5, 1996 | Supplement 4Efficacy (new indication or use) | Approved | None posted |
| Jan 8, 1993 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Omniscan287MG/ML · injectable;injection | Gadodiamide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 5, 2025 | Supplement 52Labeling · Standard review | Approved | |
| Aug 14, 2024 | Supplement 49Labeling · Standard review | Approved | |
| Jul 23, 2024 | Supplement 51Labeling · Standard review | Approved | |
| Jan 26, 2024 | Supplement 50Labeling · Standard review | Approved | |
| Nov 7, 2018 | Supplement 47Labeling · Standard review | Approved | |
| Apr 26, 2018 | Supplement 46Labeling · Standard review | Approved | |
| Jun 6, 2016 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Nov 14, 2014 | Supplement 43Labeling · Standard review | Approved | |
| Jun 23, 2014 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| May 14, 2014 | Supplement 40Manufacturing | Approved | None posted |
| Apr 3, 2014 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Aug 27, 2013 | Supplement 39Labeling · Standard review | Approved | |
| Dec 20, 2010 | Supplement 37Labeling | Approved | |
| Dec 14, 2007 | Supplement 35Labeling · Standard review | Approved | |
| Sep 5, 2007 | Supplement 34Labeling · Standard review | Approved | |
| Nov 15, 2002 | Supplement 23Manufacturing · Standard review | Approved | |
| Aug 12, 2002 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jul 8, 2002 | Supplement 18Labeling · Standard review | Approved | |
| Jun 28, 2002 | Supplement 22Labeling · Standard review | Approved | |
| May 20, 2002 | Supplement 21Manufacturing · Standard review | Approved | |
| Mar 15, 2002 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jul 30, 2001 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Mar 13, 2001 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jan 17, 2001 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Oct 3, 1997 | Supplement 15Labeling · Standard review | Approved | |
| Mar 27, 1997 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Mar 19, 1997 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Feb 5, 1996 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | None posted |
| Feb 5, 1996 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | None posted |
| Feb 5, 1996 | Supplement 4Efficacy (new indication or use) | Approved | None posted |
| Feb 17, 1995 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Nov 4, 1994 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1994 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Apr 26, 1993 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1993 | 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
