ACTIVE SUBSTANCE / INN

AMINO ACIDS

Brand name(s): AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINOSYN II 8.5% W/ELECTROLYTES, AMINOSYN II 10% W/ ELECTROLYTES, Maapliv, AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINOSYN II 7% W/ ELECTROLYTES, AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER, HEPATAMINE 8%, AMINOSYN II 3.5% M
FDA LISTED
EMA LISTED
DISCONTINUED
AUTHORISED
NDA019437
Maple Syrup Urine Disease
ACTIVE SUBSTANCE
Amino Acids
REGULATORS
FDA · EMA
SPONSORS / MAH
ICU MEDICAL INC, B BRAUN, ABBOTT
TOTAL APPLICATIONS
11
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
HEPATAMINE 8%NDA018676B BRAUNDiscontinued
AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINERNDA019505ABBOTTDiscontinued
AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINERNDA019564ABBOTTDiscontinued
AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINERNDA019564ABBOTTDiscontinued
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINERNDA019564ABBOTTDiscontinued
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINERNDA019564ABBOTTDiscontinued
AMINOSYN II 8.5% W/ELECTROLYTESNDA019437ICU MEDICAL INCDiscontinued
AMINOSYN II 7% W/ ELECTROLYTESNDA019437ICU MEDICAL INCDiscontinued
AMINOSYN II 10% W/ ELECTROLYTESNDA019437ICU MEDICAL INCDiscontinued
AMINOSYN II 3.5% MNDA019437ICU MEDICAL INCDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
MaaplivRecordati Rare DiseasesAuthorised28/07/2025Maple Syrup Urine Disease

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