Regulatory PathRegulatory requirements compared

Active substance

Selegiline

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ELDEPRYL 5MG TABS5 mgTablet · Oral use100 Tablet ContainerSAR 202.90NCE · PrescriptionORION PHARMAWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
SELEGILINE HYDROCHLORIDE5MGtablet · oralPHARMAZONEPrescription1 Apr 1997
SELEGILINE HYDROCHLORIDE5MGtablet · oralAPOTEXPrescription6 Jun 1997
SELEGILINE HYDROCHLORIDE5MGcapsule · oralNOVITIUM PHARMAPrescription30 Nov 1998
SELEGILINE HYDROCHLORIDE5MGcapsule · oralAPOTEXPrescription4 Dec 1998
EMSAM6MG/24HR; 9MG/24HR; 12MG/24HRfilm, extended release · transdermalSOMERSETPrescription27 Feb 2006
EMSAM6MG; 9MG; 12MGsystem · transdermalSOMERSETPrescription27 Feb 2006
SELEGILINE HYDROCHLORIDE5MGcapsule · oralRISINGPrescription2 Apr 2019
SELEGILINE HYDROCHLORIDE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralQUAGENDiscontinued5 Jun 1989
ELDEPRYL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralQUAGENDiscontinued15 May 1996
SELEGILINE HYDROCHLORIDE5MGtablet · oralG AND W LABS INCDiscontinued2 Aug 1996
SELEGILINE HYDROCHLORIDE5MGtablet · oralCHARTWELL MOLECULESDiscontinued2 Aug 1996
SELEGILINE HYDROCHLORIDE5MGtablet · oralCHARTWELL MOLECULESDiscontinued2 Aug 1996
SELEGILINE HYDROCHLORIDE5MGtablet · oralCOSETTE PHARMS NCDiscontinued27 Jan 1997
SELEGILINE HYDROCHLORIDE5MGtablet · oralNOVITIUM PHARMADiscontinued26 Nov 1997
SELEGILINE HYDROCHLORIDE5MGtablet · oralKENTONDiscontinued30 Apr 1998
SELEGILINE HYDROCHLORIDE5MGtablet · oralCOSETTE PHARMS NCDiscontinued25 Nov 1998
SELEGILINE HYDROCHLORIDE5MGcapsule · oralLANNETT CO INCDiscontinued15 Sep 2003
ZELAPAR1.25MGtablet, orally disintegrating · oralBAUSCHDiscontinued14 Jun 2006

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
SELEGILINE022306415 MGTABLET · ORALAA PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACEMSAM 12 MG/24 HOURS PATCH$75.39812per EA23 Sep 2026
US NADACEMSAM 6 MG/24 HOURS PATCH$74.99706per EA23 Sep 2026
US NADACEMSAM 9 MG/24 HOURS PATCH$75.17807per EA23 Sep 2026
US NADACSELEGILINE HCL 5 MG CAPSULE$0.75631per EA23 Sep 2026
US NADACSELEGILINE HCL 5 MG TABLET$0.76567per EA23 Sep 2026
NHS Drug TariffSelegiline 10mg tablets£32.23100 tablet1 Oct 2026
NHS Drug TariffSelegiline 5mg tablets£16.52100 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.

Safety signals and safety-related labeling changes

  • US FDA 16 Jun 2021 ZELAPAR — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 14 Jul 2017 EMSAM — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for selegiline →

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.