Regulatory PathRegulatory requirements compared

Active substances

Mannitol + Sorbitol

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
SORBITOL-MANNITOL IN PLASTIC CONTAINER540MG/100ML;2.7GM/100MLsolution · irrigationOTSUKA ICU MEDCLPrescription22 Feb 1980
SORBITOL-MANNITOL540MG/100ML;2.7GM/100MLsolution · irrigationHOSPIRADiscontinued20 Aug 1971
SORBITOL-MANNITOL IN PLASTIC CONTAINER540MG/100ML;2.7GM/100MLsolution · irrigationHOSPIRADiscontinued21 Jun 1976

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CYSTOSOL W 3% HEXITOLS00799963500 MG / 100 ML; 2.5 G / 100 MLLIQUID · IRRIGATIONBAXTER CORPORATION
SORBITOL MANNITOL IRRIGATION0049880727 MG / ML; 5.4 MG / MLSOLUTION · IRRIGATIONICU MEDICAL CANADA INC

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.