Regulatory PathRegulatory requirements compared

Active substance

Sulfadiazine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
SULFADIAZINE500MGtablet · oralEPIC PHARMA LLCPrescription29 Jul 1994
SULFADIAZINE500MGtablet · oralLEDERLEDiscontinued11 Aug 1941
SULFADIAZINE SODIUM250MG/MLinjectable · injectionLEDERLEDiscontinued11 Aug 1941
SULFADIAZINE500MGtablet · oralLILLYDiscontinued26 Aug 1941
SULFADIAZINE500MGtablet · oralCHARTWELL MOLECULARDiscontinued5 Jul 1978
SULFADIAZINE500MGtablet · oralIMPAX LABSDiscontinued
SULFADIAZINE500MGtablet · oralEVERYLIFEDiscontinued
SULFADIAZINE300MGtablet · oralABBVIEDiscontinued

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
SULFADIAZINE 500MG TABLETS BPPL 29831/0191WOCKHARDT UK LIMITEDPOM

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACSULFADIAZINE 500 MG TABLET$15.06467per EA23 Sep 2026
NHS Drug TariffSulfadiazine 500mg tablets£395.4256 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)

  • 6.5.4. Antipneumocystosis and antitoxoplasmosis medicines · core
    Toxoplasmosis
    Oral > Solid: 500 mg

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.