Is Metaraminol approved by the US FDA?

Drugs@FDA lists 6 application product lines for Metaraminol, including METARAMINOL BITARTRATE (Prescription); ARAMINE (Discontinued); METARAMINOL BITARTRATE (Discontinued); METARAMINOL BITARTRATE (Discontinued); METARAMINOL BITARTRATE (Discontinued).

Is Metaraminol authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 8 products containing Metaraminol, including METARAMINOL 0.5 MG/ML, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE; METARAMINOL 0.5MG/ML SOLUTION FOR INJECTION; METARAMINOL 0.5MG/ML SOLUTION FOR INJECTION/INFUSION; METARAMINOL 10MG/ML SOLUTION FOR INJECTION OR INFUSION; METARAMINOL 10MG/ML SOLUTION FOR INJECTION/INFUSION.

Active substance

Metaraminol

US FDA 6
UK MHRA 8

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
METARAMINOL BITARTRATE	EQ 10MG BASE/ML	injectable · injection	AZURITY	Prescription	24 Aug 2021
ARAMINE	EQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	MERCK	Discontinued	29 Sep 1954
METARAMINOL BITARTRATE	EQ 10MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Discontinued	17 Apr 1972
METARAMINOL BITARTRATE	EQ 10MG BASE/ML	injectable · injection	ABRAXIS PHARM	Discontinued	22 Sep 1972
METARAMINOL BITARTRATE	EQ 10MG BASE/ML	injectable · injection	ELKINS SINN	Discontinued
METARAMINOL BITARTRATE	EQ 10MG BASE/ML; EQ 20MG BASE/ML	injectable · injection	GD SEARLE LLC	Discontinued

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
METARAMINOL 0.5 MG/ML, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE	PL 14434/0042	LABORATOIRE AGUETTANT	POM
METARAMINOL 0.5MG/ML SOLUTION FOR INJECTION	PL 29831/0739	WOCKHARDT UK LIMITED	POM
METARAMINOL 0.5MG/ML SOLUTION FOR INJECTION	PL 56021/0012	TORBAY PHARMACEUTICALS LIMITED	POM
METARAMINOL 0.5MG/ML SOLUTION FOR INJECTION/INFUSION	PL 42973/0003	PHEBRA LIMITED	POM
METARAMINOL 10MG/ML SOLUTION FOR INJECTION OR INFUSION	PL 29831/0740	WOCKHARDT UK LIMITED	POM
METARAMINOL 10MG/ML SOLUTION FOR INJECTION OR INFUSION	PL 35533/0167	ASPIRE PHARMA LIMITED	POM
METARAMINOL 10MG/ML SOLUTION FOR INJECTION OR INFUSION	PL 56021/0011	TORBAY PHARMACEUTICALS LIMITED	POM
METARAMINOL 10MG/ML SOLUTION FOR INJECTION/INFUSION	PL 42973/0002	PHEBRA LIMITED	POM

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.