Drugs / Isovue 370
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (10) | US (FDA) | ISOVUE-250 | — | 1986-09-10 – 2025-10-10 | fda.gov ↗ |
| Approved | US (FDA) | ISOVUE-250 | — | 1985-12-31 | fda.gov ↗ |
Trials 0
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT02171247 Comparator | Apr 2008 → Dec 2010 | — | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT02170688 Comparator | Feb 2004 → Jul 2014 | — | Duke University | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Isovue 370 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02170688 ↗ |
| Modality | Diagnostic / imaging agent | “contrast material for a CT scan” NCT02170688 ↗ |
| Route | Intravenous | “IV contrast volume” NCT02170688 ↗ |