Is Dobutamine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Dobutamine, including Cardutrex (12.5 mg/ml, Concentrate for solution for infusion, SAR 157.75); DOBUJECT 50MG-ML(250MG-5ML) AMPOULE (50 mg/ml, Concentrate for peritoneal dialysis solution, SAR 101.55); DOBUTAMINE HCL 250MG-20ML VIAL (12.5 mg/ml, Solution for injection, SAR 31.55); DOBUTAMINE JPI 250 mg/20 ml solution for IV infusion (12.5 mg/ml, Solution for infusion, SAR 31.55).

Is Dobutamine approved by the US FDA?

Drugs@FDA lists 16 application product lines for Dobutamine, including DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER (Prescription); DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER (Prescription); DOBUTAMINE HYDROCHLORIDE (Prescription); DOBUTAMINE HYDROCHLORIDE (Prescription); DOBUTAMINE HYDROCHLORIDE (Prescription).

Active substance

Dobutamine

SFDA 7
US FDA 16
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
Cardutrex	12.5 mg/ml	Concentrate for solution for infusion · Intravenous use	5 Vial	SAR 157.75	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
DOBUJECT 50MG-ML(250MG-5ML) AMPOULE	50 mg/ml	Concentrate for peritoneal dialysis solution · Intravenous use	5 Ampoule	SAR 101.55	Generic · Prescription	PRIMEX PHARMACEUTICALS OY	Valid
DOBUTAMINE HCL 250MG-20ML VIAL	12.5 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 31.55	Generic · Prescription	Pfizer Australia Pty LTD	Valid
DOBUTAMINE JPI 250 mg/20 ml solution for IV infusion	12.5 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 31.55	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
DOBUTAMINE JPI 250 mg/20 ml solution for IV infusion	12.5 mg/ml	Solution for infusion · Intravenous use	10 Vial	SAR 203.10	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
DOBUJECT 50MG-ML(250MG-5ML) AMPOULE	50 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 140.40	Generic · Prescription	BAYER OY	Withdrawn by MAH · Not Marketed
DOBUTREX 250 MG VIAL	250 mg	Concentrate for peritoneal dialysis solution · Intravenous use	1 Vial	SAR 32.20	NCE · OTC	Eli Lilly and Company	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BRADYCARDIA; BURN MANAGEMENT; HYPOTENSION; Septic Shock

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

Product	Strength	Form · route	Applicant	Status	First approved
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 200MG BASE/100ML; EQ 100MG BASE/100ML; EQ 50MG BASE/100ML; EQ 400MG BASE/100ML	injectable · injection	HOSPIRA	Prescription	27 Sep 1993
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML; EQ 100MG BASE/100ML; EQ 200MG BASE/100ML; EQ 400MG BASE/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	27 Sep 1993
DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	injectable · injection	HOSPIRA	Prescription	29 Nov 1993
DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	31 Oct 1994
DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	injectable · injection	HAINAN POLY	Prescription	21 Dec 2022
DOBUTREX	EQ 12.5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	LILLY	Discontinued	18 Jul 1978
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%	EQ 50MG BASE/100ML; EQ 100MG BASE/100ML; EQ 200MG BASE/100ML	injectable · injection	HOSPIRA	Discontinued	27 Sep 1993
DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	injectable · injection	TEVA PARENTERAL	Discontinued	19 Oct 1993
DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	injectable · injection	WATSON LABS	Discontinued	30 Nov 1993
DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	injectable · injection	HOSPIRA	Discontinued	16 Feb 1995
DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	injectable · injection	TELIGENT	Discontinued	21 Feb 1995
DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	injectable · injection	BAXTER HLTHCARE	Discontinued	26 Sep 1996
DOBUTAMINE HYDROCHLORIDE	EQ 1.25GM BASE/100ML	injectable · injection	HOSPIRA	Discontinued	27 Sep 1996
DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	injectable · injection	WATSON LABS INC	Discontinued	18 Feb 1998
DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	injectable · injection	DR REDDYS	Discontinued	31 Mar 1998
DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	injectable · injection	LUITPOLD	Discontinued	25 Jun 1998

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DOBUTAMINE INJECTION USP	02242010	12.5 MG / ML	LIQUID · INTRAVENOUS	SANDOZ CANADA INCORPORATED
DOBUTAMINE INJECTION USP	02462729	12.5 MG / ML	SOLUTION · INTRAVENOUS	HIKMA CANADA LIMITED

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.