Regulatory PathRegulatory requirements compared

Active substances

Potassium phosphate dibasic + Potassium phosphate monobasic

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML); 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML); 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)solution · intravenousFRESENIUS KABI USAPrescription26 Nov 2019
POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML); 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)solution · intravenousFRESENIUS KABI USAPrescription26 Nov 2019
POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML); 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML); 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)solution · intravenousAM REGENTPrescription2 Oct 2023
POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML); 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML); 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)solution · intravenousAMNEALPrescription10 Oct 2023
POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML); 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)solution · intravenousSOMERSET THERAPS LLCPrescription11 Jul 2024
POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)solution · intravenousAMNEALPrescription26 Jul 2024
POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML); 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML); 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)solution · intravenousCIPLAPrescription24 Jan 2025
POTASSIUM PHOSPHATES3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)solution · intravenousHOSPIRAPrescription11 Sep 2025
POTASSIUM PHOSPHATES1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML); 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML); 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)solution · intravenousCAPLINPrescription12 Mar 2026
POTASSIUM PHOSPHATES4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)solution · intravenousCMP DEV LLCDiscontinued19 Sep 2019

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
POTASSIUM PHOSPHATES00804789236 MG / ML; 224 MG / MLLIQUID · INTRAVENOUSSANDOZ CANADA INCORPORATED
POTASSIUM PHOSPHATES INJECTION, USP02139545236 MG / ML; 224 MG / MLSOLUTION · INTRAVENOUSFRESENIUS KABI CANADA LTD

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.