MANNITOL 20% IN PLASTIC CONTAINER
Details
- Status
- Prescription
- First Approved
- 1987-01-08
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
MANNITOL 20% IN PLASTIC CONTAINER Approval History
What MANNITOL 20% IN PLASTIC CONTAINER Treats
3 indicationsMANNITOL 20% IN PLASTIC CONTAINER is approved for 3 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Intracranial Pressure
- Cerebral Edema
- Intraocular Pressure
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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.
MANNITOL 20% IN PLASTIC CONTAINER FDA Label Details
ProIndications & Usage
FDA Label (PDF)OSMITROL is indicated for: • The reduction of intracranial pressure and treatment of cerebral edema; • The reduction of elevated intraocular pressure. OSMITROL is an osmotic diuretic, indicated for the reduction of: • intracranial pressure and treatment of cerebral edema. • elevated intraocular pressure.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.