DANTRIUM (dantrolene sodium)
DANTRIUM is indicated for the treatment of Malignant Hyperthermia.
Details
- Status
- Prescription
- First Approved
- 1974-01-15
- Routes
- ORAL, INJECTION
- Dosage Forms
- CAPSULE, INJECTABLE
DANTRIUM Approval History
What DANTRIUM Treats
1 indicationsDANTRIUM is approved for 1 conditions since its original approval in 1974. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Malignant Hyperthermia
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02829268 results posted | 201607006 R21DK113487 | Ph 1, Ph 2 | completed | A Clinical Trial of Dantrolene Sodium in Pediatric and Adult Patients With Wolfram Syndrome |
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.
DANTRIUM FDA Label Details
Indications & Usage
FDA Label (PDF)DANTRIUM is indicated for the treatment of Malignant Hyperthermia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.