Regulatory PathRegulatory requirements compared

Active substances

Donepezil + Memantine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
NAMZARIC10MG;14MG; 10MG;28MG; 10MG;7MG; 10MG;21MGcapsule, extended release · oralABBVIEPrescription23 Dec 2014
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MG; 10MG;28MG; 10MG;7MG; 10MG;21MGcapsule, extended release · oralAMNEALPrescription27 Jan 2017
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;21MGcapsule, extended release · oralANI PHARMSPrescription15 Dec 2023
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MG; 10MG;28MGcapsule, extended release · oralMACLEODS PHARMSPrescription15 Jul 2025
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE10MG;14MG; 10MG;28MGcapsule, extended release · oralXIAMEN LP PHARM COPrescription15 Jul 2025

EMA European Union — centrally authorised medicines

Acrescent H. Lundbeck A/S · Refused · ATC N06D

Therapeutic indication (EMA)

Treatment of Alzheimers disease

Balaxur Merz Pharmaceuticals GmbH · Refused · ATC N06DA52

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMEMANTINE-DONEPEZIL ER 14-10 MG$6.48822per EA23 Sep 2026
US NADACMEMANTINE-DONEPEZIL ER 28-10 MG$8.44457per EA23 Sep 2026
US NADACNAMZARIC 14 MG-10 MG CAPSULE$19.84763per EA23 Sep 2026
US NADACNAMZARIC 21 MG-10 MG CAPSULE$19.95748per EA23 Sep 2026
US NADACNAMZARIC 28 MG-10 MG CAPSULE$19.80435per EA23 Sep 2026
US NADACNAMZARIC 7 MG-10 MG CAPSULE$19.82669per 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.