Regulatory PathRegulatory requirements compared

Active substance

Acetazolamide

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Acetazolamide250 mgTablet · Oral use30 BlisterSAR 17.05Generic · PrescriptionREMEDICAValid
DIAMOX 250MG TAB.250 mgTablet · Oral use25 BlisterSAR 19.65Generic · PrescriptionWYETHWithdrawn by MAH · Not Marketed
DIAMOX SUSTETS 500 MG500 mgCapsule · Oral use100 Tablet ContainerSAR 77.45NCE · PrescriptionWYETHWithdrawn by MAH · Not Marketed
DIAMOX SUSTETS 500 MG500 mgCapsule · Oral use30 Tablet ContainerSAR 26.55NCE · PrescriptionWYETHWithdrawn by MAH · Not Marketed
DIAMOX TAB 125MG125 mgTablet · Oral use100 Tablet ContainerSAR 38.15NCE · PrescriptionWYETHWithdrawn by MAH · Not Marketed
DIAMOX VIALS 500 MG500 mgInjection · Parenteral use1 VialSAR 16.30NCE · PrescriptionWYETHWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

NON-INFECTIOUS UVEITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
ACETAZOLAMIDE250MGtablet · oralCHARTWELL MOLECULARPrescription31 Mar 1978
ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALinjectable · injectionHIKMA PHARMSPrescription28 Feb 1995
ACETAZOLAMIDE125MG; 250MGtablet · oralTAROPrescription28 May 1997
ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALinjectable · injectionXGEN PHARMSPrescription10 Dec 2008
ACETAZOLAMIDE500MGcapsule, extended release · oralHERITAGE PHARMAPrescription10 Dec 2008
ACETAZOLAMIDE500MGcapsule, extended release · oralINDICUS PHARMAPrescription14 Jul 2011
ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALinjectable · injectionMYLAN ASIPrescription9 May 2012
ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALinjectable · injectionAVET LIFESCIENCESPrescription19 Dec 2014
ACETAZOLAMIDE500MGcapsule, extended release · oralMPP PHARMAPrescription29 Mar 2016
ACETAZOLAMIDE500MGcapsule, extended release · oralNOVAST LABSPrescription30 Sep 2016
ACETAZOLAMIDE125MG; 250MGtablet · oralHERITAGE PHARMAPrescription27 Oct 2016
ACETAZOLAMIDE125MG; 250MGtablet · oralSTRIDES PHARMAPrescription20 Nov 2017
ACETAZOLAMIDE500MGcapsule, extended release · oralACCORD HLTHCAREPrescription18 Oct 2018
ACETAZOLAMIDE500MGcapsule, extended release · oralCADILAPrescription16 Jan 2019
ACETAZOLAMIDE500MGcapsule, extended release · oralALEMBICPrescription19 Feb 2019
ACETAZOLAMIDE SODIUMEQ 500MG BASE/VIALinjectable · injectionZYDUS PHARMSPrescription15 Apr 2019
ACETAZOLAMIDE125MG; 250MGtablet · oralNOVITIUM PHARMAPrescription17 Oct 2019
ACETAZOLAMIDE125MG; 250MGtablet · oralADAPTISPrescription18 Oct 2019
ACETAZOLAMIDE500MGcapsule, extended release · oralMICRO LABS LTD INDIAPrescription1 Oct 2020
ACETAZOLAMIDE125MG; 250MGtablet · oralMANKIND PHARMAPrescription7 Oct 2020
ACETAZOLAMIDE125MG; 250MGtablet · oralSOMERSET THERAPS LLCPrescription22 Feb 2021
ACETAZOLAMIDE125MG; 250MGtablet · oralRUBICON RESEARCHPrescription19 Aug 2021
ACETAZOLAMIDE125MG; 250MGtablet · oralZYDUS LIFESCIENCESPrescription4 Apr 2023
ACETAZOLAMIDE125MG; 250MGtablet · oralNE RX PHARMAPrescription9 May 2023
ACETAZOLAMIDE125MG; 250MGtablet · oralEPIC PHARMA LLCPrescription14 May 2024

18 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ACETAZOLAMIDE00545015250 MGTABLET · ORALAA PHARMA INC
ACETAZOLAMIDE FOR INJECTION USP02537893500 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUSMARCAN PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACACETAZOLAMIDE 125 MG TABLET$0.09649per EA23 Sep 2026
US NADACACETAZOLAMIDE 250 MG TABLET$0.13397per EA23 Sep 2026
US NADACACETAZOLAMIDE ER 500 MG CAP$0.28822per EA23 Sep 2026
NHS Drug TariffAcetazolamide 250mg tablets£9.80112 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)

  • 21.4. Ophthalmological preparations > Miotics and antiglaucoma medicines · core
    Primary open-angle glaucoma
    Oral > Solid: 250 mg

Safety signals and safety-related labeling changes

All safety entries for acetazolamide →

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.