Regulatory PathRegulatory requirements compared

Active substance

Lorazepam

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ATIVAN TABLETS 1 MG1 mgTablet · Oral use20 BlisterSAR 14.90NCE · PrescriptionWYETHWithdrawn by MAH · Not Marketed
ATIVAN TABLETS 2 MG2 mgTablet · Oral use20 BlisterSAR 19.80NCE · PrescriptionWYETHWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
ATIVAN0.5MG; 1MG; 2MGtablet · oralBAUSCHPrescription30 Sep 1977
ATIVAN2MG/ML; 4MG/MLinjectable · injectionHIKMA PHARMSPrescription25 Jul 1980
LORAZEPAM0.5MGtablet · oralPrescription21 Apr 1987
LORAZEPAM2MG; 0.5MG; 1MGtablet · oralSANDOZPrescription21 Apr 1987
LORAZEPAM1MGtablet · oralSANDOZPrescription21 Apr 1987
LORAZEPAM INTENSOL2MG/MLconcentrate · oralHIKMA PHARMSPrescription28 Jun 1991
LORAZEPAM0.5MGtablet · oralWATSON LABSPrescription31 Oct 1991
LORAZEPAM1MGtablet · oralWATSON LABSPrescription31 Oct 1991
LORAZEPAM2MGtablet · oralWATSON LABSPrescription31 Oct 1991
LORAZEPAM2MG/ML; 4MG/MLinjectable · injectionHOSPIRAPrescription12 Apr 1994
LORAZEPAM2MG/MLinjectable · injectionRISINGPrescription23 Jul 1998
LORAZEPAM0.5MG; 1MG; 2MGtablet · oralSUN PHARM INDS LTDPrescription29 Aug 2001
LORAZEPAM2MG/MLinjectable · injectionINTL MEDICATION SYSPrescription15 Nov 2004
LORAZEPAM0.5MG; 1MG; 2MGtablet · oralOXFORD PHARMSPrescription10 May 2006
LORAZEPAM0.5MG; 1MG; 2MGtablet · oralANI PHARMSPrescription13 Dec 2006
LORAZEPAM0.5MG; 1MG; 2MGtablet · oralLEADINGPrescription30 Jul 2007
LORAZEPAM2MG/MLconcentrate · oralAMNEAL PHARMSPrescription23 Dec 2009
LORAZEPAM2MG/MLconcentrate · oralPHARM ASSOCPrescription15 Jun 2010
LORAZEPAM0.5MG; 1MG; 2MGtablet · oralAUROBINDO PHARMAPrescription22 Dec 2017
LOREEV XR1MG; 2MG; 3MG; 1.5MGcapsule, extended release · oralALMATICAPrescription27 Aug 2021
LORAZEPAM2MG/MLinjectable · injectionFRESENIUS KABI USAPrescription18 Nov 2024
LORAZEPAM0.5MG; 1MG; 2MGtablet · oralGRAVITI PHARMSPrescription24 Jul 2025
LORAZEPAM0.5MGtablet · oralMUTUAL PHARMDiscontinued10 Dec 1985
LORAZEPAM1MGtablet · oralMUTUAL PHARMDiscontinued10 Dec 1985
LORAZEPAM2MGtablet · oralMUTUAL PHARMDiscontinued10 Dec 1985

49 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-LORAZEPAM006557400.5 MGTABLET · ORALAPOTEX INC
APO-LORAZEPAM006557591 MGTABLET · ORALAPOTEX INC
APO-LORAZEPAM006557672 MGTABLET · ORALAPOTEX INC
LORAZEPAM INJECTION USP022432784 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSSANDOZ CANADA INCORPORATED
LORAZEPAM INJECTION, USP025509624 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSFRESENIUS KABI CANADA LTD
LORAZEPAM SUBLINGUAL024107450.5 MGTABLET · SUBLINGUALAA PHARMA INC
LORAZEPAM SUBLINGUAL024107531 MGTABLET · SUBLINGUALAA PHARMA INC
LORAZEPAM SUBLINGUAL024107612 MGTABLET · SUBLINGUALAA PHARMA INC
PMS-LORAZEPAM007281870.5 MGTABLET · ORALPHARMASCIENCE INC
PMS-LORAZEPAM007281951 MGTABLET · ORALPHARMASCIENCE INC
PMS-LORAZEPAM007282092 MGTABLET · ORALPHARMASCIENCE INC
PRO-LORAZEPAM006556430.5 MGTABLET · ORALPRO DOC LIMITEE
PRO-LORAZEPAM006556511 MGTABLET · ORALPRO DOC LIMITEE
PRO-LORAZEPAM006556782 MGTABLET · ORALPRO DOC LIMITEE
TEVA-LORAZEPAM006377421 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-LORAZEPAM006377502 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-LORAZEPAM007111010.5 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLORAZEPAM 0.5 MG TABLET$0.03443per EA23 Sep 2026
US NADACLORAZEPAM 1 MG TABLET$0.03671per EA23 Sep 2026
US NADACLORAZEPAM 2 MG TABLET$0.07314per EA23 Sep 2026
US NADACLORAZEPAM 2 MG/ML ORAL CONCENT$0.68632per ML23 Sep 2026
US NADACLORAZEPAM 2 MG/ML VIAL$2.17153per ML23 Sep 2026
US NADACLORAZEPAM INTENSOL 2 MG/ML$0.68632per ML23 Sep 2026
NHS Drug TariffLorazepam 1mg orodispersible tablets£37.5828 tablet1 Oct 2026
NHS Drug TariffLorazepam 1mg tablets£2.0528 tablet1 Oct 2026
NHS Drug TariffLorazepam 1mg/ml oral solution sugar free£270.44150 ml1 Oct 2026
NHS Drug TariffLorazepam 2.5mg tablets£2.2228 tablet1 Oct 2026
NHS Drug TariffLorazepam 250microgram tablets£55.2028 tablet1 Oct 2026
NHS Drug TariffLorazepam 4mg/1ml solution for injection ampoules£199.0010 ampoule1 Oct 2026
NHS Drug TariffLorazepam 500microgram tablets£1.5428 tablet1 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)

  • 5.1.1. Antiseizure medicines · core
    Status epilepticus
    Parenteral > General injections > IV: 2 mg per mL in 1 mL ampoule; 4 mg per mL in 1 mL ampoule
  • 24.3. Medicines for anxiety disorders · core
    Therapeutic equivalent to diazepam for Anxiety

Safety signals and safety-related labeling changes

All safety entries for lorazepam →

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.