Regulatory PathRegulatory requirements compared

Active substance

Maprotiline

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
LUDIOMIL TAB. 10 MG10 mgTablet · Oral use50 Tablet ContainerSAR 23.40NCE · PrescriptionAMDIPHARMAWithdrawn by MAH · Not Marketed
LUDIOMIL TAB. 10 MG10 mgTablet · Oral use50 Tablet ContainerSAR 23.40NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
LUDIOMIL TAB. 25 MG.25 mgTablet · Oral use30 Tablet ContainerSAR 25.55NCE · PrescriptionAMDIPHARMAWithdrawn by MAH · Not Marketed
LUDIOMIL TAB. 25 MG.25 mgTablet · Oral use30 Tablet ContainerSAR 25.55NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
LUDIOMIL TAB. 50 MG50 mgTablet · Oral use30 Tablet ContainerSAR 45.25NCE · PrescriptionAMDIPHARMAWithdrawn by MAH · Not Marketed
LUDIOMIL TAB. 50 MG50 mgTablet · Oral use30 Tablet ContainerSAR 45.25NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
LUDIOMIL25MG; 50MG; 75MGtablet · oralNOVARTISDiscontinued1 Dec 1980
MAPROTILINE HYDROCHLORIDE25MGtablet · oralHERITAGE PHARMADiscontinued1 Jun 1988
MAPROTILINE HYDROCHLORIDE50MGtablet · oralHERITAGE PHARMADiscontinued1 Jun 1988
MAPROTILINE HYDROCHLORIDE75MGtablet · oralWATSON LABSDiscontinued1 Jun 1988
MAPROTILINE HYDROCHLORIDE50MG; 25MG; 75MGtablet · oralRISINGDiscontinued3 Oct 1988
MAPROTILINE HYDROCHLORIDE25MGtablet · oralWATSON LABSDiscontinued
MAPROTILINE HYDROCHLORIDE50MGtablet · oralWATSON LABSDiscontinued
MAPROTILINE HYDROCHLORIDE75MGtablet · oralWATSON LABSDiscontinued
MAPROTILINE HYDROCHLORIDE25MGtablet · oralAM THERAPDiscontinued
MAPROTILINE HYDROCHLORIDE50MGtablet · oralAM THERAPDiscontinued
MAPROTILINE HYDROCHLORIDE75MGtablet · oralAM THERAPDiscontinued

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.