Regulatory PathRegulatory requirements compared

Active substance

Primidone

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
MYSOLINE SYRUP50 mg/mlSyrup · Oral use1 BottleSAR 8.05NCE · PrescriptionAstraZenecaWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
MYSOLINE250MG; 50MGtablet · oralVALEANTPrescription8 Mar 1954
PRIMIDONE250MG; 50MGtablet · oralLANNETTPrescription1 Dec 1978
PRIMIDONE250MGtablet · oralWATSON LABSPrescription7 Feb 1979
PRIMIDONE50MG; 250MGtablet · oralOXFORD PHARMSPrescription24 Feb 2005
PRIMIDONE50MG; 250MGtablet · oralTP ANDA HOLDINGSPrescription29 Sep 2005
PRIMIDONE50MG; 250MGtablet · oralAMNEAL PHARMPrescription23 Apr 2008
PRIMIDONE50MG; 250MG; 125MGtablet · oralRUBICON RESEARCHPrescription28 Jun 2022
PRIMIDONE50MG; 250MGtablet · oralCARNEGIEPrescription23 Jan 2024
PRIMIDONE50MG; 250MGtablet · oralHIKMA INTL PHARMSDiscontinued27 Jul 2006
PRIMIDONE50MG; 250MGtablet · oralIMPAX LABSDiscontinued12 Feb 2008
PRIMIDONE50MG; 250MGtablet · oralCHARTWELL RXDiscontinued3 Oct 2008
PRIMIDONE250MGtablet · oralWATSON LABSDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PRIMIDONE00396761250 MGTABLET · ORALAA PHARMA INC
PRIMIDONE00399310125 MGTABLET · ORALAA PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPRIMIDONE 125 MG TABLET$1.37851per EA23 Sep 2026
US NADACPRIMIDONE 250 MG TABLET$0.22758per EA23 Sep 2026
US NADACPRIMIDONE 50 MG TABLET$0.09137per EA23 Sep 2026
NHS Drug TariffPrimidone 125mg tablets£65.0050 tablet1 Oct 2026
NHS Drug TariffPrimidone 250mg tablets£42.43100 tablet1 Oct 2026
NHS Drug TariffPrimidone 50mg tablets£118.71100 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.

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.