Regulatory PathRegulatory requirements compared

Active substance

Sterile water for injection

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER100%liquid · n/aOTSUKA ICU MEDCLPrescription18 Feb 1980
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER100%liquid · n/aBAXTER HLTHCAREPrescription30 Jun 1982
STERILE WATER FOR INJECTION100% (10ML); 100% (20ML); 100% (50ML); 100% (100ML); 100% (5.2ML)liquid · n/aHOSPIRAPrescription27 Oct 1982
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%liquid · n/aHOSPIRAPrescription27 Oct 1982
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER100%liquid · n/aFRESENIUS KABI USAPrescription16 Jan 1984
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER100%liquid · n/aB BRAUNPrescription29 Feb 1988
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER100%liquid · n/aOTSUKA ICU MEDCLPrescription26 Dec 1989
STERILE WATER FOR INJECTION100% (10ML)liquid · n/aHIKMA PHARMSPrescription2 Sep 2015
STERILE WATER FOR INJECTION100%liquid · n/aFRESENIUS KABI USAPrescription24 Nov 2017
STERILE WATER FOR INJECTION100% (1ML); 100% (2.5ML); 100% (3ML); 100% (5ML); 100% (10ML)liquid · n/aMEDEFIL INCPrescription2 Dec 2019
STERILE WATER FOR INJECTION100% (5ML)liquid · n/aNEPHRONPrescription10 Feb 2021
STERILE WATER FOR INJECTION100%liquid · n/aHIKMAPrescription31 Jan 2023
STERILE WATER FOR INJECTION100% (10ML); 100% (20ML)liquid · n/aNEXUSPrescription11 Jul 2023
STERILE WATER FOR INJECTION100% (10ML); 100% (20ML); 100% (5ML)liquid · n/aAM REGENTPrescription29 Aug 2023
STERILE WATER FOR INJECTION100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**liquid · n/aHOSPIRADiscontinued27 Oct 1982
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER100%liquid · n/aB BRAUNDiscontinued2 Mar 1984
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER100%liquid · n/aTARODiscontinued11 Aug 2006
STERILE WATER FOR INJECTION100% (20ML)liquid · n/aHIKMA PHARMSDiscontinued2 Sep 2015
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%liquid · n/aABRAXIS PHARMDiscontinued
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%liquid · n/aABRAXIS PHARMDiscontinued

Safety signals and safety-related labeling changes

All safety entries for sterile water for injection →

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.