Regulatory PathRegulatory requirements compared

Active substance

Doxapram

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
DOPRAM20MG/MLinjectable · injectionHIKMA PHARMSPrescription23 Jun 1965
DOXAPRAM HYDROCHLORIDE20MG/MLinjectable · injectionCHARTWELL INJECTABLEPrescription10 Jan 2003
DOXAPRAM HYDROCHLORIDE20MG/MLinjectable · injectionWATSON LABSDiscontinued30 Jan 1992

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
DOPRAM INFUSIONPL 12762/0623MERCURY PHARMACEUTICALS LIMITEDPOM
DOPRAM INJECTIONPL 12762/0573MERCURY PHARMACEUTICALS LIMITEDPOM
DOXAPRAM HYDROCHLORIDE 20 MG/ML SOLUTION FOR INJECTIONPL 39280/0017SYNCHRONY PHARMA LIMITEDPOM
DOXAPRAM HYDROCHLORIDE 20MG/ML SOLUTION FOR INJECTIONPL 12762/0573MERCURY PHARMACEUTICALS LIMITEDPOM
DOXAPRAM HYDROCHLORIDE 2MG/ML SOLUTION FOR INFUSIONPL 12762/0623MERCURY PHARMACEUTICALS LIMITEDPOM

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.