Is Phentolamine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Phentolamine.

Is Phentolamine approved by the US FDA?

Drugs@FDA lists 5 application product lines for Phentolamine, including PHENTOLAMINE MESYLATE (Prescription); ORAVERSE (Prescription); PHENTOLAMINE MESYLATE (Prescription); RYZUMVI (Prescription); REGITINE (Discontinued).

Active substance

Phentolamine

SFDA 1
US FDA 5
Health Canada 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
REGITINE AMP	10 mg/ml	Injection · Intravenous use	1 Ampoule	SAR 15.95	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
PHENTOLAMINE MESYLATE	5MG/VIAL	injectable · injection	HIKMA PHARMS	Prescription	11 Mar 1998
ORAVERSE	0.4MG/1.7ML	injectable · injection	SEPTODONT HOLDING	Prescription	9 May 2008
PHENTOLAMINE MESYLATE	5MG/VIAL	injectable · injection	PRECISION DOSE INC	Prescription	14 Jul 2017
RYZUMVI	EQ 0.75% BASE	solution · ophthalmic	FAMYGEN LIFE SCI	Prescription	25 Sep 2023
REGITINE	5MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	NOVARTIS	Discontinued	30 Jan 1952

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ORAVERSE	02421666	0.4 MG / 1.7 ML	SOLUTION · SUBMUCOSAL	SEPTODONT
PHENTOLAMINE MESYLATE INJECTION SANDOZ STANDARD	02243737	5 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	SANDOZ CANADA INCORPORATED

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.