Regulatory PathRegulatory requirements compared

Active substance

Etomidate

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
AMIDATE2MG/MLinjectable · injectionHOSPIRAPrescription7 Sep 1982
ETOMIDATE2MG/MLinjectable · injectionHIKMA PHARMSPrescription4 Nov 1996
ETOMIDATE2MG/MLinjectable · injectionZYDUS PHARMSPrescription18 Jul 2014
ETOMIDATE2MG/MLinjectable · injectionHIKMAPrescription25 Feb 2016
ETOMIDATE2MG/MLinjectable · injectionMYLAN LABS LTDPrescription7 Feb 2017
ETOMIDATE2MG/MLinjectable · injectionEUGIA PHARMAPrescription24 Feb 2017
ETOMIDATE2MG/MLinjectable · injectionGLANDPrescription18 Apr 2017
ETOMIDATE2MG/MLinjectable · injectionCAPLINPrescription18 Dec 2020
ETOMIDATE2MG/MLinjectable · injectionRISINGDiscontinued2 Jan 2009
ETOMIDATE2MG/MLinjectable · injectionLUITPOLDDiscontinued22 Dec 2009
ETOMIDATE2MG/MLinjectable · injectionPH HEALTHDiscontinued20 Jun 2012
ETOMIDATE2MG/MLinjectable · injectionAVET LIFESCIENCESDiscontinued13 Aug 2014

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ETOMIDATE INJECTION, USP025375082 MG / MLSOLUTION · INTRAVENOUSFRESENIUS KABI CANADA LTD
TOMVI024986502 MG / MLSOLUTION · INTRAVENOUSSTERIMAX INC

Safety signals and safety-related labeling changes

  • US FDA 27 Apr 2017 AMIDATE — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for etomidate →

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.