Reduction of intracranial pressure and treatment of cerebral edema. Sold as Mannitol 25%, Osmitrol 5% In Water, Osmitrol 10% In Water, Osmitrol 20% In Water, Osmitrol 15% In Water and 19 more. Every FDA application for this active ingredient: 12 branded and 7 generic.
As of Nov 13, 2026, FDA lists 19 applications for Mannitol (sold as Mannitol 25%, Osmitrol 5% In Water, Osmitrol 10% In Water and others), first approved Jun 8, 1964, with 4 new uses approved and 2 published complete response letters.
| Product | Part | Spending, 2024 | Change | Beneficiaries |
|---|---|---|---|---|
| Bronchitol | Part D | $126K | +1% | 0 |
| Mannitol | Part B | $17K | -43% | 1,092 |
| Mannitol | Part D | $0K | -73% | 12 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jun 8, 1964 | Osmitrol 5% In Water, Osmitrol 10% In WaterNDA 13684 · New formulation or manufacturer | Baxter Hlthcare | 77 | Marketed |
| Jul 30, 1964 | Mannitol 20%NDA 14738 · New formulation or manufacturer | B Braun | 10 | Discontinued |
| Oct 8, 1965 | Mannitol 5%, Mannitol 10%NDA 16080 · New formulation or manufacturer | B Braun | 10 | Discontinued |
| Dec 22, 1967 | Mannitol 5%, Mannitol 10%NDA 16269 · New formulation or manufacturer | Hospira | 34 | Marketed |
| Nov 18, 1969 | ResectisolNDA 16704 · New formulation or manufacturer | B Braun | 1 | Discontinued |
| Aug 11, 1972 | Mannitol 25%ANDA 80677 | Fresenius Kabi USA | 14 | Marketed |
| Aug 29, 1975 | Mannitol 25%ANDA 83051 | Intl Medication | 9 | Discontinued |
| Feb 10, 1978 | Resectisol In Plastic ContainerNDA 16772 · New formulation or manufacturer | B Braun | 26 | Discontinued |
| Jun 10, 1980 | Mannitol 25%ANDA 86754 | Abraxis Pharm | 0 | Discontinued |
| Jan 21, 1982 | Mannitol 25%ANDA 87409 | Luitpold | 12 | Discontinued |
| Jan 8, 1987 | Mannitol 5% In Plastic Container, Mannitol 10% In Plastic ContainerNDA 19603 · New formulation or manufacturer | Otsuka Icu Medcl | 18 | Marketed |
| May 6, 1987 | Mannitol 25%ANDA 89239 | Igi Labs Inc | 0 | Discontinued |
| May 6, 1987 | Mannitol 25%ANDA 89240 | Igi Labs Inc | 0 | Discontinued |
| Jul 26, 1993 | Mannitol 5% In Plastic Container, Mannitol 10% In Plastic ContainerNDA 20006 · New formulation or manufacturer | B Braun | 7 | Marketed |
| Oct 5, 2010 | AridolNDA 22368 · New dosage form | Pharmaxis Europe | 1 | Marketed |
| Oct 30, 2020 | BronchitolNDA 202049 · New indication | Pharmaxis Europe | 0 | Marketed |
| — | Mannitol 25%ANDA 87460 | Watson Labs | 0 | Discontinued |
| — | Mannitol 25%NDA 5620 | Merck | 0 | Discontinued |
| — | Mannitol 10%, Mannitol 20%NDA 16472 | Miles | 0 | Discontinued |
| Letter | Product | Now |
|---|---|---|
| Jun 19, 2019 | Mannitol | Approved |
| Mar 18, 2013 | Bronchitol (mannitol)Clinical, Product Quality, Labeling | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA
