Regulatory PathRegulatory requirements compared

Active substances

Amoxicillin + Clarithromycin + Lansoprazole

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)500MG;500MG;30MGcapsule, tablet, capsule, delayed rel pellets · oralSANDOZPrescription4 Mar 2014
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)500MG;500MG;30MGcapsule, tablet, capsule, delayed rel pellets · oralRISINGPrescription7 Oct 2016
PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule, tablet, capsule, delayed rel pellets · oralTAKEDA PHARMS USADiscontinued2 Dec 1997
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)500MG;500MG;30MGcapsule, tablet, capsule, delayed rel pellets · oralANI PHARMSDiscontinued30 Aug 2013

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN02470780500 MG / CAP; 30 MG / CAP; 500 MG / TABKIT; TABLET; CAPSULE (DELAYED-RELEASE); CAPSULE · ORALAA PHARMA INC

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.