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ACTIVE SUBSTANCE / INN

MANNITOL

Brand name(s): OSMITROL 5% IN WATER, MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL 10% IN PLASTIC CONTAINER, OSMITROL 15% IN WATER IN PLASTIC CONTAINER, OSMITROL 5% IN WATER IN PLASTIC CONTAINER, OSMITROL 20% IN WATER, Bronchitol, OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL 25%
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA013684
NDA019603
ACTIVE SUBSTANCE
Mannitol
REGULATORS
FDA · EMA
SPONSORS / MAH
OTSUKA ICU MEDCL, Pharmaxis Europe Limited, IGI LABS INC
TOTAL APPLICATIONS
11
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
MANNITOL 25%ANDA089240IGI LABS INCDiscontinued
MANNITOL 15% IN PLASTIC CONTAINERNDA019603OTSUKA ICU MEDCLDiscontinued
MANNITOL 5% IN PLASTIC CONTAINERNDA019603OTSUKA ICU MEDCLDiscontinued
MANNITOL 20% IN PLASTIC CONTAINERNDA019603OTSUKA ICU MEDCLPrescription
MANNITOL 10% IN PLASTIC CONTAINERNDA019603OTSUKA ICU MEDCLDiscontinued
OSMITROL 20% IN WATER IN PLASTIC CONTAINERNDA013684BAXTER HLTHCAREPrescription
OSMITROL 5% IN WATER IN PLASTIC CONTAINERNDA013684BAXTER HLTHCAREPrescription
OSMITROL 20% IN WATERNDA013684BAXTER HLTHCAREPrescription
OSMITROL 5% IN WATERNDA013684BAXTER HLTHCAREPrescription
OSMITROL 15% IN WATER IN PLASTIC CONTAINERNDA013684BAXTER HLTHCAREPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
BronchitolPharmaxis Europe LimitedAuthorised13/04/2012Cystic Fibrosis

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