Regulatory PathRegulatory requirements compared

Active substance

Triazolam

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
HALCION0.25MG; 0.125MGtablet · oralPFIZERPrescription15 Nov 1982
TRIAZOLAM0.125MG; 0.25MGtablet · oralINGENUS PHARMS LLCPrescription20 Oct 2020
TRIAZOLAM0.125MG; 0.25MGtablet · oralZYDUS PHARMSPrescription28 Dec 2022
HALCION0.5MGtablet · oralPFIZERDiscontinued15 Nov 1982
TRIAZOLAM0.125MG; 0.25MGtablet · oralPHARMOBEDIENTDiscontinued25 Mar 1994
TRIAZOLAM0.125MG; 0.25MGtablet · oralHIKMA PHARMSDiscontinued1 Jun 1994
TRIAZOLAM0.125MG; 0.25MGtablet · oralWATSON LABSDiscontinued20 Oct 1995
TRIAZOLAM0.125MG; 0.25MGtablet · oralBRECKENRIDGEDiscontinued8 Nov 2022

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
TRIAZOLAM008085710.25 MGTABLET · ORALAA PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACTRIAZOLAM 0.125 MG TABLET$0.26282per EA23 Sep 2026
US NADACTRIAZOLAM 0.25 MG TABLET$0.30835per EA23 Sep 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.

Safety signals and safety-related labeling changes

  • US FDA 27 Oct 2021 HALCION — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for triazolam →

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.