Regulatory PathRegulatory requirements compared

Active substances

Naproxen + Sumatriptan

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
TREXIMET500MG;EQ 85MG BASEtablet · oralAZURITYPrescription15 Apr 2008
SUMATRIPTAN AND NAPROXEN SODIUM500MG;EQ 85MG BASEtablet · oralAUROBINDO PHARMA LTDPrescription15 Feb 2018
SUMATRIPTAN AND NAPROXEN SODIUM500MG;EQ 85MG BASEtablet · oralSUN PHARMPrescription20 Jul 2018
SUMATRIPTAN AND NAPROXEN SODIUM500MG;EQ 85MG BASEtablet · oralRISINGPrescription4 Sep 2018
TREXIMET60MG;EQ 10MG BASEtablet · oralAZURITYDiscontinued15 Apr 2008

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
JAMP SUMATRIPTAN / NAPROXEN SODIUM02566974500 MG; 85 MGTABLET · ORALJAMP PHARMA CORPORATION
SUVEXX0249630585 MG; 500 MGTABLET · ORALARALEZ PHARMACEUTICALS CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACSUMATRIPTAN-NAPROXEN 85-500 MG$10.46339per EA23 Sep 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.