Sold as Omniscan. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 2 applications for Gadodiamide (sold as Omniscan), first approved Jan 8, 1993, with 3 new uses approved and 0 published complete response letters.
| Non-Contrast Versus Contrast-Enhanced MRI in Colorectal Liver MetastasesLiver Metastases, Liver Neoplasms · Assiut University | — | Not yet recruiting | Oct 5, 2026 |
| Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 YearsMotor Function, Cognitive Function · Guerbet | Phase 4 | Recruiting | May 4, 2020 |
| Jan 8, 1993 | OmniscanNDA 20123 · New molecular entity | Ge Healthcare | 34 | Marketed |
| Sep 5, 2007 | OmniscanNDA 22066 · New formulation or manufacturer | Ge Healthcare | 12 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Ge Healthcare