Is Dutasteride + Tamsulosin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Dutasteride + Tamsulosin, including DUODART Capsule (0.5,0.4 mg,mg, Capsule, hard, SAR 103.60); Dusta plus (0.5,0.4 mg,mg, Capsule, hard, SAR 90.45).

Is Dutasteride + Tamsulosin approved by the US FDA?

Drugs@FDA lists 5 application product lines for Dutasteride + Tamsulosin, including JALYN (Prescription); DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (Prescription); DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (Prescription); DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (Discontinued); DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (Discontinued).

Active substances

Dutasteride + Tamsulosin

SFDA 3
US FDA 5
Health Canada 1
US price lines 1
NHS prices 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DUODART Capsule	0.5,0.4 mg,mg	Capsule, hard · Oral use	30 Tablet Container	SAR 103.60	NCE · Prescription	Glaxo Saudi Arabia Ltd	Valid
Dusta plus	0.5,0.4 mg,mg	Capsule, hard · Oral use	30 Bottle	SAR 90.45	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
DUODART Capsule	0.4, 0.5 mg	Capsule, hard · Oral use	90 Tablet Container	SAR 388.50	NCE · Prescription	Glaxo Saudi Arabia Ltd	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BENIGN PROSTATIC HYPERTROPHY

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

Product	Strength	Form · route	Applicant	Status	First approved
JALYN	0.5MG;0.4MG	capsule · oral	WAYLIS THERAP	Prescription	14 Jun 2010
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	capsule · oral	ZYDUS PHARMS	Prescription	24 May 2018
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	capsule · oral	AUROBINDO PHARMA	Prescription	18 Jul 2024
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	capsule · oral	PH HEALTH	Discontinued	26 Feb 2014
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	capsule · oral	ACTAVIS LABS FL INC	Discontinued	20 Nov 2015

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JALYN	02372010	0.5 MG; 0.4 MG	CAPSULE (IMMEDIATE- AND EXTENDED-RELEASE · ORAL	GLAXOSMITHKLINE INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DUTASTERIDE-TAMSULOSIN 0.5-0.4	$1.97362	per EA	23 Sep 2026
NHS Drug Tariff	Tamsulosin 400microgram / Dutasteride 500microgram capsules	£4.35	30 capsule	1 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.

Components

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.