Regulatory PathRegulatory requirements compared

Active substance

Droxidopa

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
NORTHERA100MG; 200MG; 300MGcapsule · oralLUNDBECK NA LTDPrescription18 Feb 2014
DROXIDOPA300MG; 100MG; 200MGcapsule · oralANNORAPrescription18 Feb 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralMSN PHARMS INCPrescription18 Feb 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralZYDUS PHARMSPrescription18 Feb 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralALKEM LABS LTDPrescription18 Feb 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralSCIEGEN PHARMSPrescription18 Feb 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralSUN PHARMPrescription18 Feb 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralAUROBINDO PHARMA LTDPrescription18 Feb 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralJUBILANT CADISTAPrescription18 Feb 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralBIONPHARMAPrescription28 Apr 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralSOMERSET THERAPS LLCPrescription5 May 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralADAPTISPrescription1 Nov 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralLUPIN PHARMSDiscontinued18 Feb 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralHIKMA PHARMSDiscontinued18 Feb 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralTEVA PHARMS USA INCDiscontinued18 Feb 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralUPSHER SMITH LABSDiscontinued18 Feb 2021
DROXIDOPA100MG; 200MG; 300MGcapsule · oralCHARTWELL RXDiscontinued5 May 2022

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDROXIDOPA 100 MG CAPSULE$0.47244per EA23 Sep 2026
US NADACDROXIDOPA 200 MG CAPSULE$0.9008per EA23 Sep 2026
US NADACDROXIDOPA 300 MG CAPSULE$1.84448per 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.

Safety signals and safety-related labeling changes

  • US FDA 10 Feb 2017 NORTHERA — 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

All safety entries for droxidopa →

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.