Regulatory PathRegulatory requirements compared

Active substance

Dexamfetamine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
DEXEDRINE SPANSULE5MG; 10MG; 15MGcapsule, extended release · oralIMPAX LABS INCPrescription2 Aug 1976
DEXTROAMPHETAMINE SULFATE5MG; 10MGtablet · oralBARRPrescription31 Jan 2001
DEXTROAMPHETAMINE SULFATE5MG; 10MGtablet · oralSPECGX LLCPrescription29 Jan 2002
DEXTROAMPHETAMINE SULFATE5MG; 10MG; 15MGcapsule, extended release · oralSPECGX LLCPrescription6 May 2003
DEXTROAMPHETAMINE SULFATE5MG/5MLsolution · oralPRASCOPrescription29 Jan 2008
DEXTROAMPHETAMINE SULFATE2.5MG; 5MG; 7.5MG; 10MG; 15MG; 20MG; 30MGtablet · oralAZURITYPrescription25 Oct 2011
DEXTROAMPHETAMINE SULFATE5MG; 10MG; 15MGcapsule, extended release · oralACTAVIS ELIZABETHPrescription30 Nov 2012
DEXTROAMPHETAMINE SULFATE5MG/5MLsolution · oralTRIS PHARMA INCPrescription29 May 2013
DEXTROAMPHETAMINE SULFATE5MG; 10MGtablet · oralAUROLIFE PHARMA LLCPrescription31 Jul 2013
DEXTROAMPHETAMINE SULFATE5MG; 10MGtablet · oralAVANTHI INCPrescription23 Nov 2015
DEXTROAMPHETAMINE SULFATE5MG; 10MGtablet · oralNOVEL LABS INCPrescription16 Mar 2016
DEXTROAMPHETAMINE SULFATE5MG; 10MGtablet · oralNUVO PHARMPrescription18 Oct 2017
DEXTROAMPHETAMINE SULFATE2.5MG; 5MG; 7.5MG; 10MG; 15MG; 20MG; 30MGtablet · oralWINDER LABS LLCPrescription7 Jun 2021
XELSTRYM4.5MG/9HR; 9MG/9HR; 13.5MG/9HR; 18MG/9HRsystem · transdermalNOVEN PHARMS INCPrescription22 Mar 2022
DEXTROSTAT5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralSHIREDiscontinued29 May 1975
DEXTROAMPHETAMINE SULFATE5MG; 10MGtablet · oralLANNETTDiscontinued29 Oct 1975
DEXEDRINE5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**elixir · oralGLAXOSMITHKLINEDiscontinued26 Feb 1976
DEXEDRINE5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralGLAXOSMITHKLINEDiscontinued26 Feb 1976
FERNDEX5MGtablet · oralFERNDALE LABSDiscontinued15 Jun 1977
DEXTROAMPHETAMINE SULFATE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralLANNETTDiscontinued20 Jun 1980
DEXTROAMPHETAMINE SULFATE5MGtablet · oralSTRIDES PHARMA INTLDiscontinued13 May 1999
DEXTROAMPHETAMINE SULFATE5MG; 10MG; 15MGcapsule, extended release · oralPHARMAZONEDiscontinued18 Jan 2002
DEXTROAMPHETAMINE SULFATE5MGtablet · oralNESHER PHARMSDiscontinued31 Oct 2002
DEXTROAMPHETAMINE SULFATE10MGtablet · oralNESHER PHARMSDiscontinued31 Oct 2002
DEXTROAMPHETAMINE SULFATE5MG; 10MG; 15MGcapsule, extended release · oralABLEDiscontinued25 Aug 2004

16 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
DEXEDRINE019245165 MGTABLET · ORALKNIGHT THERAPEUTICS INC.
DEXEDRINE SPANSULE0192455910 MGCAPSULE (SUSTAINED-RELEASE) · ORALKNIGHT THERAPEUTICS INC.
DEXEDRINE SPANSULE0192456715 MGCAPSULE (SUSTAINED-RELEASE) · ORALKNIGHT THERAPEUTICS INC.
DEXTROAMPHETAMINE024432365 MGTABLET · ORALAA PHARMA INC
PMS-DEXTROAMPHETAMINE025666055 MGTABLET · ORALPHARMASCIENCE INC
TEVA-DEXTROAMPHETAMINE SR0244831910 MGCAPSULE (SUSTAINED-RELEASE) · ORALTEVA CANADA LIMITED
TEVA-DEXTROAMPHETAMINE SR0244832715 MGCAPSULE (SUSTAINED-RELEASE) · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDEXTROAMPHETAMINE 10 MG TAB$0.37325per EA23 Sep 2026
US NADACDEXTROAMPHETAMINE 15 MG TAB$5.4497per EA23 Sep 2026
US NADACDEXTROAMPHETAMINE 2.5 MG TAB$3.95113per EA23 Sep 2026
US NADACDEXTROAMPHETAMINE 20 MG TAB$5.41457per EA23 Sep 2026
US NADACDEXTROAMPHETAMINE 30 MG TAB$5.48996per EA23 Sep 2026
US NADACDEXTROAMPHETAMINE 5 MG TAB$0.38361per EA23 Sep 2026
US NADACDEXTROAMPHETAMINE 5 MG/5 ML$1.14342per ML23 Sep 2026
US NADACDEXTROAMPHETAMINE 7.5 MG TAB$5.83093per EA23 Sep 2026
US NADACDEXTROAMPHETAMINE ER 10 MG CAP$1.05126per EA23 Sep 2026
US NADACDEXTROAMPHETAMINE ER 15 MG CAP$1.33772per EA23 Sep 2026
US NADACDEXTROAMPHETAMINE ER 5 MG CAP$1.10063per EA23 Sep 2026
US NADACXELSTRYM 13.5 MG/9 HR PATCH$16.25846per EA23 Sep 2026
NHS Drug TariffDexamfetamine 10mg tablets£39.7830 tablet1 Oct 2026
NHS Drug TariffDexamfetamine 20mg tablets£79.5630 tablet1 Oct 2026
NHS Drug TariffDexamfetamine 5mg tablets£19.8528 tablet1 Oct 2026
NHS Drug TariffDexamfetamine 5mg/5ml oral solution sugar free£190.66150 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

  • US FDA 23 Apr 2026 ADDERALL XR 10 — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 23 Apr 2026 MYDAYIS — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 23 Sep 2025 XELSTRYM — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 23 Sep 2025 DEXEDRINE SPANSULE — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 13 Oct 2023 ADDERALL 10 — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 13 Oct 2023 ADDERALL 12.5 — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 13 Oct 2023 ADDERALL 15 — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 13 Oct 2023 ADDERALL 20 — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 13 Oct 2023 ADDERALL 30 — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 13 Oct 2023 ADDERALL 5 — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 13 Oct 2023 ADDERALL 7.5 — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 13 Oct 2023 DEXEDRINE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for dexamfetamine →

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.