Regulatory PathRegulatory requirements compared

Active substance

Phenoxybenzamine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
PHENOXYBENZAMINE HYDROCHLORIDE10MGcapsule · oralPH HEALTHPrescription24 Jan 2017
PHENOXYBENZAMINE HYDROCHLORIDE10MGcapsule · oralAMNEALPrescription27 Oct 2020
PHENOXYBENZAMINE HYDROCHLORIDE10MGcapsule · oralNOVITIUM PHARMAPrescription19 Jul 2022
PHENOXYBENZAMINE HYDROCHLORIDE10MGcapsule · oralAUROBINDO PHARMAPrescription8 May 2023
PHENOXYBENZAMINE HYDROCHLORIDE10MGcapsule · oralRISINGPrescription20 Jun 2023
DIBENZYLINE10MGcapsule · oralADVANZ PHARMADiscontinued26 Jan 1953
PHENOXYBENZAMINE HYDROCHLORIDE10MGcapsule · oralHIKMA PHARMSDiscontinued16 Jul 2012

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
DIBENYLINE 10MG CAPSULESPL 12762/0224MERCURY PHARMACEUTICALS LIMITEDPOM
PHENOXYBENZAMINE 10MG CAPSULESPL 12762/0224MERCURY PHARMACEUTICALS LIMITEDPOM

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffPhenoxybenzamine 10mg capsules£129.2130 capsule1 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.

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.