Regulatory PathRegulatory requirements compared

Active substance

Methazolamide

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
METHAZOLAMIDE25MG; 50MGtablet · oralANI PHARMSPrescription30 Jun 1993
METHAZOLAMIDE25MG; 50MGtablet · oralCHARTWELL RXPrescription30 Jun 1993
METHAZOLAMIDE25MG; 50MGtablet · oralPHARMOBEDIENTPrescription27 Jan 1994
METHAZOLAMIDE25MG; 50MGtablet · oralBAUSCH AND LOMB INCPrescription5 Oct 2018
METHAZOLAMIDE25MG; 50MGtablet · oralTAGIPrescription18 Oct 2022
METHAZOLAMIDE25MG; 50MGtablet · oralAJANTA PHARMA LTDPrescription9 Feb 2026
NEPTAZANE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralLEDERLEDiscontinued26 Jan 1959
METHAZOLAMIDE25MG; 50MGtablet · oralPHARMOBEDIENTDiscontinued28 Aug 1996
METHAZOLAMIDE25MG; 50MGtablet · oralAPPLIED ANALDiscontinued17 Jul 1997

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
METHAZOLAMIDE0224588250 MGTABLET · ORALAA PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMETHAZOLAMIDE 25 MG TABLET$0.62747per EA23 Sep 2026
US NADACMETHAZOLAMIDE 50 MG TABLET$1.46836per 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.

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.