Regulatory PathRegulatory requirements compared

Active substance

Amino acids

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Aminoplasmal paed10 %Solution for infusion · Intravenous use12 BagSAR 721.05Generic · PrescriptionB. BRAUNValid

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

ProductStrengthForm · routeApplicantStatusFirst approved
TROPHAMINE6% (6GM/100ML)injectable · injectionB BRAUNPrescription20 Jul 1984
TROPHAMINE 10%10% (10GM/100ML)injectable · injectionB BRAUNPrescription20 Jul 1984
TRAVASOL 5.5% IN PLASTIC CONTAINER5.5% (5.5GM/100ML)injectable · injectionBAXTER HLTHCAREPrescription23 Aug 1984
TRAVASOL 8.5% IN PLASTIC CONTAINER8.5% (8.5GM/100ML)injectable · injectionBAXTER HLTHCAREPrescription23 Aug 1984
TRAVASOL 10% IN PLASTIC CONTAINER10% (10MG/100ML)injectable · injectionBAXTER HLTHCAREPrescription23 Aug 1984
AMINOSYN-PF 7%7% (7GM/100ML)injectable · injectionOTSUKA ICU MEDCLPrescription6 Sep 1985
AMINOSYN-PF 10%10% (10GM/100ML)injectable · injectionOTSUKA ICU MEDCLPrescription17 Oct 1986
AMINOSYN II 10% IN PLASTIC CONTAINER10% (10GM/100ML)injectable · injectionOTSUKA ICU MEDCLPrescription19 Dec 1991
AMINOSYN II 15% IN PLASTIC CONTAINER15% (15GM/100ML)injectable · injectionOTSUKA ICU MEDCLPrescription19 Dec 1991
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER15% (15GM/100ML)injectable · injectionBAXTER HLTHCAREPrescription30 Aug 1996
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER20% (20GM/100ML)injectable · injectionBAXTER HLTHCAREPrescription26 Aug 1998
PREMASOL 6% IN PLASTIC CONTAINER6% (6GM/100ML)injectable · injectionBAXTER HLTHCAREPrescription19 Jun 2003
PREMASOL 10% IN PLASTIC CONTAINER10% (10GM/100ML)injectable · injectionBAXTER HLTHCAREPrescription19 Jun 2003
AMINO ACIDS15%(150GM/1000ML); 15%(300GM/2000ML)injectable · injectionB BRAUNPrescription13 Apr 2012
FREAMINE 8.5%8.5% (8.5GM/100ML)injectable · injectionB BRAUNDiscontinued24 Sep 1971
FREAMINE II 8.5%8.5% (8.5GM/100ML)injectable · injectionB BRAUNDiscontinued24 Sep 1971
FREAMINE III 8.5%8.5% (8.5GM/100ML)injectable · injectionB BRAUNDiscontinued24 Sep 1971
FREAMINE III 10%10% (10GM/100ML)injectable · injectionB BRAUNDiscontinued24 Sep 1971
FREAMINE HBC 6.9%6.9% (6.9GM/100ML)injectable · injectionB BRAUNDiscontinued24 Sep 1971
AMINOSYN 5%5% (5GM/100ML)injectable · injectionICU MEDICAL INCDiscontinued3 Dec 1975
AMINOSYN 7%7% (7GM/100ML)injectable · injectionICU MEDICAL INCDiscontinued3 Dec 1975
AMINOSYN 10%10% (10GM/100ML)injectable · injectionICU MEDICAL INCDiscontinued3 Dec 1975
AMINOSYN 8.5%8.5% (8.5GM/100ML)injectable · injectionICU MEDICAL INCDiscontinued3 Dec 1975
AMINOSYN 7% (PH6)7% (7GM/100ML)injectable · injectionICU MEDICAL INCDiscontinued3 Dec 1975
AMINOSYN 8.5% (PH6)8.5% (8.5GM/100ML)injectable · injectionICU MEDICAL INCDiscontinued3 Dec 1975

29 more — full table

Safety signals and safety-related labeling changes

All safety entries for amino acids →

Combinations containing Amino acids

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.