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Data updated: Mar 10, 2026

OSMITROL 20% IN WATER

MANNITOL Osmotic Activity
Ophthalmology Approved 1964-06-08
2
Indications
--
Phase 3 Trials
61
Years on Market

Details

Status
Prescription
First Approved
1964-06-08
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: MANNITOL

OSMITROL 20% IN WATER Approval History

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What OSMITROL 20% IN WATER Treats

3 indications

OSMITROL 20% IN WATER is approved for 3 conditions since its original approval in 1964. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Intracranial Pressure
  • Cerebral Edema
  • Intraocular Pressure
Source: FDA Label

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Trial Timeline

Full development history with FDA approval milestones

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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.

OSMITROL 20% IN WATER FDA Label Details

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Indications & 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.