ISOVUE-M 300
Details
- Status
- Prescription
- First Approved
- 1985-12-31
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ISOVUE-M 300 Approval History
What ISOVUE-M 300 Treats
12 FDA approvalsOriginally approved for its first indication in 1985 . Covers 12 distinct patient populations.
- Other (12)
Other
(12 approvals)- • Approved indication (Dec 1985)
- • Approved indication (Sep 1986)
- • Approved indication (Oct 1986)
- • Approved indication (Jul 1987)
- • Approved indication (Oct 1989)
- • Approved indication (Jan 1990)
- • Approved indication (May 1990)
- • Approved indication (Sep 1990)
- • Approved indication (Jul 1992)
- • Approved indication (May 1995)
- • Approved indication (Mar 1996)
- • Approved indication (Oct 2025) NewLabel Letter
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ISOVUE-M 300 FDA Label Details
ProIndications & Usage
FDA Label (PDF)Iopamidol Injection is indicated for intrathecal administration in adult neuroradiology including myelography (lumbar, thoracic, cervical, total columnar), and for contrast enhancement of computed tomographic (CECT) cisternography and ventriculography. Iopamidol Injection, 41% is indicated for thoraco-lumbar myelography in children over the age of two years.
ISOVUE-M 300 Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.