Regulatory PathRegulatory requirements compared

Active substance

Midodrine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
GUTRON TAB 2.5 MG TAB2.5 mgTablet · Oral use50 BlisterSAR 16.55NCE · PrescriptionTakeda Manufacturing Austria AGValid
GUTRON TAB 2.5 MG TAB2.5 mgTablet · Oral use20 BlisterSAR 8.75NCE · PrescriptionTakeda Manufacturing Austria AGValid
GUTRON Injection*2.5 mg/mlInjection · Oral use5 AmpouleSAR 12.45NCE · PrescriptionTakeda Manufacturing Austria AGWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

DIALYSIS; HYPOTENSION

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

ProductStrengthForm · routeApplicantStatusFirst approved
MIDODRINE HYDROCHLORIDE2.5MG; 5MG; 10MGtablet · oralMYLAN PHARMS INCPrescription10 Sep 2003
ORVATEN2.5MG; 5MG; 10MGtablet · oralBEIJING YILINGPrescription3 Nov 2004
MIDODRINE HYDROCHLORIDE2.5MG; 5MG; 10MGtablet · oralAPOTEXPrescription12 Sep 2006
MIDODRINE HYDROCHLORIDE2.5MG; 5MG; 10MGtablet · oralPH HEALTHPrescription29 Oct 2018
MIDODRINE HYDROCHLORIDE2.5MG; 5MG; 10MGtablet · oralUNIQUEPrescription2 Nov 2018
MIDODRINE HYDROCHLORIDE2.5MG; 5MG; 10MGtablet · oralRUBICON RESEARCHPrescription19 Aug 2019
MIDODRINE HYDROCHLORIDE2.5MG; 5MG; 10MGtablet · oralAUROBINDO PHARMA LTDPrescription10 Aug 2020
MIDODRINE HYDROCHLORIDE2.5MG; 5MG; 10MGtablet · oralZYDUS LIFESCIENCESPrescription1 Sep 2020
MIDODRINE HYDROCHLORIDE2.5MG; 5MG; 10MGtablet · oralXIROMEDPrescription1 Oct 2020
MIDODRINE HYDROCHLORIDE2.5MG; 5MG; 10MGtablet · oralALEMBICPrescription21 Jan 2021
MIDODRINE HYDROCHLORIDE2.5MG; 5MG; 10MGtablet · oralNOVUGENPrescription17 Oct 2023
MIDODRINE HYDROCHLORIDE2.5MG; 5MG; 10MGtablet · oralMANKIND PHARMAPrescription1 Nov 2023
PROAMATINE2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralTAKEDA PHARMS USADiscontinued6 Sep 1996
MIDODRINE HYDROCHLORIDE2.5MG; 5MG; 10MGtablet · oralCHARTWELL RXDiscontinued11 Sep 2003
MIDODRINE HYDROCHLORIDE2.5MG; 5MG; 10MGtablet · oralIMPAX PHARMSDiscontinued27 May 2004

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-MIDODRINE022786772.5 MGTABLET · ORALAPOTEX INC
APO-MIDODRINE022786855 MGTABLET · ORALAPOTEX INC
JAMP MIDODRINE025177012.5 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP MIDODRINE025177285 MGTABLET · ORALJAMP PHARMA CORPORATION
M-MIDODRINE025471122.5 MGTABLET · ORALMANTRA PHARMA INC
M-MIDODRINE025471205 MGTABLET · ORALMANTRA PHARMA INC
MAR-MIDODRINE024739842.5 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MAR-MIDODRINE024739925 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MIDODRINE025332002.5 MGTABLET · ORALSANIS HEALTH INC
MIDODRINE025332195 MGTABLET · ORALSANIS HEALTH INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMIDODRINE HCL 10 MG TABLET$0.15125per EA7 Oct 2026
US NADACMIDODRINE HCL 2.5 MG TABLET$0.07366per EA7 Oct 2026
US NADACMIDODRINE HCL 5 MG TABLET$0.11131per EA7 Oct 2026
NHS Drug TariffMidodrine 10mg tablets£35.00100 tablet1 Oct 2026
NHS Drug TariffMidodrine 2.5mg tablets£7.15100 tablet1 Oct 2026
NHS Drug TariffMidodrine 5mg tablets£9.67100 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

All safety entries for midodrine →

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.