Regulatory PathRegulatory requirements compared

Active substances

Dextromethorphan + Quinidine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
NUEDEXTA20MG;10MGcapsule · oralOTSUKA AMERICA PHARMPrescription29 Oct 2010
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE20MG;10MGcapsule · oralACTAVIS ELIZABETHPrescription10 Oct 2017
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE20MG;10MGcapsule · oralHETERO LABS LTD IIIPrescription28 Aug 2024
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE20MG;10MGcapsule · oralSUN PHARMPrescription3 Jun 2026

EMA European Union — centrally authorised medicines

Nuedexta Jenson Pharmaceutical Services Limited · Withdrawn · authorised 24 Jun 2013 · ATC N07XX59

Therapeutic indication (EMA)

Nuedexta is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults. Efficacy has only been studied in patients with underlying amyotrophic lateral sclerosis or multiple sclerosis.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACNUEDEXTA 20-10 MG CAPSULE$26.63535per 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.