Drugs / Omnipaque 350
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (10) | US (FDA) | OMNIPAQUE 140 | — | 1986-11-26 – 1993-07-13 | fda.gov ↗ |
| Approved | US (FDA) | OMNIPAQUE 140 | — | 1985-12-26 | fda.gov ↗ |
Trials 0
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT04504331 Background | Oct 2020 → Oct 2021 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, progesterone-receptor positive breast cancer | Jennifer Lee Caswell-Jin | Terminated | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Omnipaque 350 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04504331 ↗ |
| Modality | Diagnostic / imaging agent | “IV contrast agent” NCT04504331 ↗ |
| Route | Intravenous | “IV contrast agent” NCT04504331 ↗ |