Regulatory PathRegulatory requirements compared

Active substance

Ketamine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
TEKAM 50MG-ML 10ML VIAL50 mg/mlInjection · Intravenous use1 VialSAR 26.55NCE · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Tekam10 mg/mlSolution for injection/infusion · Intramuscular and intravenous use10 VialSAR 104.20Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Tekam50 mg/mlSolution for injection/infusion · Intramuscular and intravenous use10 VialSAR 265.50Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
TEKAM 10MG-ML 10ML VIAL10 mg/mlInjection · Intravenous use1 VialSAR 6.50NCE · PrescriptionHikma Pharmaceuticals PLCWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ACUTE BIPOLAR I DEPRESSION; ANESTHESIA; ANXIETY DISORDERS; BIPOLAR II DISORDER; BURN MANAGEMENT; EPIDERMOLYSIS BULLOSA; POSTOPERATIVE PAIN

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

ProductStrengthForm · routeApplicantStatusFirst approved
KETALAREQ 10MG BASE/ML; EQ 50MG BASE/ML; EQ 100MG BASE/MLinjectable · injectionPH HEALTHPrescription19 Feb 1970
KETAMINE HYDROCHLORIDEEQ 50MG BASE/ML; EQ 100MG BASE/MLinjectable · injectionHIKMA PHARMSPrescription22 Mar 1996
KETAMINE HYDROCHLORIDEEQ 50MG BASE/ML; EQ 100MG BASE/MLinjectable · injectionHOSPIRAPrescription27 Jun 1996
KETAMINE HYDROCHLORIDEEQ 10MG BASE/ML; EQ 50MG BASE/ML; EQ 100MG BASE/MLinjectable · injectionEUGIA PHARMAPrescription28 Dec 2001
KETAMINE HYDROCHLORIDEEQ 10MG BASE/ML; EQ 50MG BASE/ML; EQ 100MG BASE/MLinjectable · injectionFRESENIUS KABI USAPrescription13 Jan 2023
KETAMINE HYDROCHLORIDEEQ 10MG BASE/ML; EQ 50MG BASE/ML; EQ 100MG BASE/MLinjectable · injectionGLANDPrescription24 Jan 2023
KETAMINE HYDROCHLORIDEEQ 50MG BASE/5ML (EQ 10MG BASE/ML)solution · intramuscular, intravenousBAXTER HLTHCARE CORPPrescription17 Sep 2025
KETAMINE HYDROCHLORIDEEQ 10MG BASE/MLinjectable · injectionCAPLINDiscontinued7 Aug 2025
KETAMINE HYDROCHLORIDEEQ 100MG BASE/10ML (EQ 10MG BASE/ML)solution · intramuscular, intravenousBAXTER HLTHCARE CORPDiscontinued17 Sep 2025
KETAMINE HCLEQ 10MG BASE/MLinjectable · injectionQUAD PHARMSDiscontinued
KETAMINE HCLEQ 50MG BASE/MLinjectable · injectionQUAD PHARMSDiscontinued
KETAMINE HCLEQ 100MG BASE/MLinjectable · injectionQUAD PHARMSDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
KETALAR0022439110 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSSEARCHLIGHT PHARMA INC
KETALAR0022440550 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSSEARCHLIGHT PHARMA INC
KETAMINE HYDROCHLORIDE INJECTION USP0224679510 MG / MLSOLUTION · INTRAVENOUS; INTRAMUSCULARSANDOZ CANADA INCORPORATED
KETAMINE HYDROCHLORIDE INJECTION USP0224679650 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSSANDOZ CANADA INCORPORATED
KETAMINE HYDROCHLORIDE INJECTION, USP0255043110 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSFRESENIUS KABI CANADA LTD
KETAMINE HYDROCHLORIDE INJECTION, USP0255045850 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSFRESENIUS KABI CANADA LTD
KETAMINE INJECTION, BP0253564550 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSSTERIMAX INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACKETALAR 500 MG/10 ML VIAL$0.67242per ML23 Sep 2026
US NADACKETAMINE 500 MG/10 ML VIAL$0.5563per ML23 Sep 2026
US NADACKETAMINE 500 MG/5 ML VIAL$1.78037per ML23 Sep 2026
NHS Drug TariffKetamine 200mg/20ml solution for injection vials£5.061 vial1 Oct 2026
NHS Drug TariffKetamine 500mg/10ml solution for injection vials£8.771 vial1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 1.1.2. General anaesthetics and oxygen > Injectable medicines · core
    Anaesthetics and therapeutic gases
    Parenteral > General injections > unspecified: 10 mg per mL in vial (as hydrochloride) (EMLc); 50 mg per mL in vial (as hydrochloride)

Safety signals and safety-related labeling changes

All safety entries for ketamine →

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.