Regulatory PathRegulatory requirements compared

Active substances

Esomeprazole + Naproxen

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE;375MG; EQ 20MG BASE;500MGtablet, delayed release · oralDR REDDYSPrescription18 Feb 2020
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE;375MG; EQ 20MG BASE;500MGtablet, delayed release · oralAJANTA PHARMA LTDPrescription6 Oct 2022
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE;375MG; EQ 20MG BASE;500MGtablet, delayed release · oralSCIEGEN PHARMSPrescription11 Oct 2023
VIMOVOEQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet, delayed release · oralHORIZONDiscontinued30 Apr 2010
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE;375MG; EQ 20MG BASE;500MGtablet, delayed release · oralPHARMOBEDIENTDiscontinued20 Jul 2021
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE;375MG; EQ 20MG BASE;500MGtablet, delayed release · oralACTAVIS LABS FL INCDiscontinued24 Aug 2022

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-NAPROXEN / ESOMEPRAZOLE0256452120 MG; 375 MGTABLET (IMMEDIATE- AND DELAYED-RELEASE) · ORALAPOTEX INC
APO-NAPROXEN / ESOMEPRAZOLE0256454820 MG; 500 MGTABLET (IMMEDIATE- AND DELAYED-RELEASE) · ORALAPOTEX INC
MYLAN-NAPROXEN/ESOMEPRAZOLE MR02443449500 MG; 20 MGTABLET (IMMEDIATE- AND DELAYED-RELEASE) · ORALMYLAN PHARMACEUTICALS ULC
MYLAN-NAPROXEN/ESOMEPRAZOLE MR02458608375 MG; 20 MGTABLET (IMMEDIATE- AND DELAYED-RELEASE) · ORALMYLAN PHARMACEUTICALS ULC
VIMOVO0236170120 MG; 375 MGTABLET (IMMEDIATE- AND DELAYED-RELEASE) · ORALXEDITON PHARMACEUTICALS INC
VIMOVO02361728500 MG; 20 MGTABLET (IMMEDIATE- AND DELAYED-RELEASE) · ORALXEDITON PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffNaproxen 500mg / Esomeprazole 20mg modified-release tablets£14.9560 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.

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.