Regulatory PathRegulatory requirements compared

Active substance

Amantadine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
PK-MERZ100 mgTablet · Oral use100 Tablet ContainerSAR 66.20NCE · PrescriptionMERZ PHARMACEUTICALValid
Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS; PARKINSONISM; SCHIZOPHRENIA

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

ProductStrengthForm · routeApplicantStatusFirst approved
AMANTADINE HYDROCHLORIDE100MGcapsule · oralUPSHER SMITH LABSPrescription7 Jan 1987
AMANTADINE HYDROCHLORIDE100MGcapsule · oralSANDOZPrescription18 Feb 1987
AMANTADINE HYDROCHLORIDE50MG/5MLsyrup · oralCHARTWELL RXPrescription28 Jun 1993
AMANTADINE HYDROCHLORIDE50MG/5MLsyrup · oralAUROBINDO PHARMA USAPrescription28 Oct 1994
AMANTADINE HYDROCHLORIDE50MG/5MLsyrup · oralPHARM ASSOCPrescription17 Jul 1995
AMANTADINE HYDROCHLORIDE50MG/5MLsyrup · oralPHARMOBEDIENTPrescription24 Dec 1998
AMANTADINE HYDROCHLORIDE100MGtablet · oralUPSHER SMITH LABSPrescription16 Dec 2002
AMANTADINE HYDROCHLORIDE100MGcapsule · oralBIONPHARMAPrescription29 May 2008
AMANTADINE HYDROCHLORIDE100MGcapsule · oralZYDUS PHARMSPrescription31 May 2016
AMANTADINE HYDROCHLORIDE100MGcapsule · oralSTRIDES PHARMAPrescription7 Jun 2017
AMANTADINE HYDROCHLORIDE100MGtablet · oralSTRIDES PHARMAPrescription9 Jun 2017
AMANTADINE HYDROCHLORIDE100MGcapsule · oralHERITAGE PHARMAPrescription12 Jun 2017
AMANTADINE HYDROCHLORIDE100MGcapsule · oralALEMBICPrescription21 Jun 2017
GOCOVRIEQ 68.5MG BASE; EQ 137MG BASEcapsule, extended release · oralSUPERNUS PHARMSPrescription24 Aug 2017
AMANTADINE HYDROCHLORIDE100MGcapsule · oralRISINGPrescription2 Mar 2020
AMANTADINE HYDROCHLORIDE100MGtablet · oralPHARMOBEDIENTPrescription10 Mar 2020
AMANTADINE HYDROCHLORIDE100MGcapsule · oralRUBICON RESEARCHPrescription21 May 2020
AMANTADINE HYDROCHLORIDE100MGtablet · oralALEMBICPrescription15 Oct 2020
AMANTADINE HYDROCHLORIDE50MG/5MLsyrup · oralPHARMOBEDIENTPrescription20 Aug 2021
AMANTADINE HYDROCHLORIDE100MGcapsule · oralONESOURCEPrescription18 Feb 2022
AMANTADINE HYDROCHLORIDE100MGcapsule · oralHUMANWELL PURACAPPrescription20 Dec 2022
AMANTADINE HYDROCHLORIDE100MGtablet · oralZHEJIANG JUTAI PHARMPrescription26 Sep 2024
SYMMETREL50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**syrup · oralENDO PHARMSDiscontinued14 Feb 1968
SYMMETREL50MG/5MLsyrup · oralENDO PHARMSDiscontinued20 Jul 1976
SYMMETREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralENDO PHARMSDiscontinued3 Nov 1980

18 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ODAN-AMANTADINE SYRUP0253860110 MG / MLSYRUP · ORALODAN LABORATORIESLTD
PDP-AMANTADINE HYDROCHLORIDE CAPSULES01990403100 MGCAPSULE · ORALPENDOPHARM DIVISION OF PHARMASCIENCE INC
PDP-AMANTADINE HYDROCHLORIDE SYRUP0202282650 MG / 5 MLSYRUP · ORALPENDOPHARM DIVISION OF PHARMASCIENCE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACAMANTADINE 100 MG CAPSULE$0.14251per EA23 Sep 2026
US NADACAMANTADINE 100 MG TABLET$0.31434per EA23 Sep 2026
US NADACAMANTADINE 50 MG/5 ML SOLUTION$0.04977per ML23 Sep 2026
NHS Drug TariffAmantadine 100mg capsules£7.5556 capsule1 Oct 2026
NHS Drug TariffAmantadine 50mg/5ml oral solution sugar free£140.00150 ml1 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.

Safety signals and safety-related labeling changes

All safety entries for amantadine →

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.