Regulatory PathRegulatory requirements compared

Active substances

Aluminium hydroxide + Magnesium trisilicate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
MALUGEL CHEWABLE TAB120, 250 mgChewable tablet · Oral use30 BlisterSAR 1.35NCE · OTCHikma Pharmaceuticals PLCWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
GAVISCON80MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 160MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet, chewable · oralCHATTEM SANOFIDiscontinued9 Dec 1983
FOAMCOAT80MG;20MGtablet, chewable · oralGUARDIAN DRUGDiscontinued4 Sep 1987
FOAMICON80MG;20MGtablet, chewable · oralNOVARTISDiscontinued28 Jun 1989
ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE80MG;20MGtablet, chewable · oralPENNEXDiscontinued

Components

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.