Is Buprenorphine + Naloxone approved by the US FDA?

Drugs@FDA lists 25 application product lines for Buprenorphine + Naloxone, including SUBOXONE (Prescription); BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (Prescription); BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (Prescription); ZUBSOLV (Prescription); BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (Prescription).

Is Buprenorphine + Naloxone authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Buprenorphine + Naloxone: Suboxone, Zubsolv.

Active substances

Buprenorphine + Naloxone

US FDA 25
EMA 2
Health Canada 12
US price lines 16
NHS prices 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
SUBOXONE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE; EQ 4MG BASE;EQ 1MG BASE; EQ 12MG BASE;EQ 3MG BASE	film · buccal, sublingual	INDIVIOR	Prescription	30 Aug 2010
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	tablet · sublingual	ACTAVIS ELIZABETH	Prescription	22 Feb 2013
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	tablet · sublingual	AMNEAL PHARMS	Prescription	22 Feb 2013
ZUBSOLV	EQ 1.4MG BASE;EQ 0.36MG BASE; EQ 5.7MG BASE;EQ 1.4MG BASE; EQ 8.6MG BASE;EQ 2.1MG BASE; EQ 11.4MG BASE;EQ 2.9MG BASE; EQ 2.9MG BASE;EQ 0.71MG BASE; EQ 0.7MG BASE;EQ 0.18MG BASE	tablet · sublingual	EDENBRIDGE PHARMS	Prescription	3 Jul 2013
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	tablet · sublingual	HIKMA PHARMS	Prescription	27 Jun 2014
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	tablet · sublingual	ETHYPHARM	Prescription	16 Oct 2015
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	tablet · sublingual	SUN PHARM	Prescription	5 Aug 2016
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	tablet · sublingual	LANNETT CO INC	Prescription	19 Sep 2016
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	tablet · sublingual	SPECGX LLC	Prescription	13 Dec 2017
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	film · buccal, sublingual	DR REDDYS LABS SA	Prescription	14 Jun 2018
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE; EQ 12MG BASE;EQ 3MG BASE	film · buccal, sublingual	DR REDDYS LABS SA	Prescription	14 Jun 2018
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE; EQ 12MG BASE;EQ 3MG BASE	film · buccal, sublingual	MYLAN TECHNOLOGIES	Prescription	14 Jun 2018
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 4MG BASE;EQ 1MG BASE; EQ 8MG BASE;EQ 2MG BASE; EQ 12MG BASE;EQ 3MG BASE	film · buccal, sublingual	ALVOGEN	Prescription	24 Jan 2019
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	tablet · sublingual	RHODES PHARMS	Prescription	30 Mar 2020
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 4MG BASE;EQ 1MG BASE	film · buccal, sublingual	MYLAN TECHNOLOGIES	Prescription	17 Apr 2020
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	tablet · sublingual	WES PHARMA INC	Prescription	17 Jul 2020
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	tablet · sublingual	ALKEM LABS LTD	Prescription	15 Jun 2021
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE; EQ 12MG BASE;EQ 3MG BASE; EQ 2MG BASE;EQ 0.5MG BASE; EQ 4MG BASE;EQ 1MG BASE	film · buccal, sublingual	DIFGEN PHARMS	Prescription	2 Jun 2022
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	tablet · sublingual	ASCENT PHARMS INC	Prescription	15 Dec 2025
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 4MG BASE;EQ 1MG BASE; EQ 8MG BASE;EQ 2MG BASE; EQ 12MG BASE;EQ 3MG BASE	film · buccal, sublingual	ASCENT PHARMS INC	Prescription	21 Jan 2026
SUBOXONE	EQ 2MG BASE;EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 8MG BASE;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · sublingual	INDIVIOR	Discontinued	8 Oct 2002
BUNAVAIL	EQ 2.1MG BASE;EQ 0.3MG BASE; EQ 4.2MG BASE;EQ 0.7MG BASE; EQ 6.3MG BASE;EQ 1MG BASE	film · buccal	BDSI	Discontinued	6 Jun 2014
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	tablet · sublingual	TEVA PHARMS USA	Discontinued	8 Sep 2014
CASSIPA	EQ 16MG BASE;EQ 4MG BASE	film · sublingual	TEVA PHARMS USA	Discontinued	7 Sep 2018
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE; EQ 8MG BASE;EQ 2MG BASE	tablet · sublingual	DR REDDYS LABS SA	Discontinued	17 Jul 2020

EMA European Union — centrally authorised medicines

Suboxone Indivior Europe Limited · Authorised · authorised 26 Sep 2006 · ATC N07BC51

Therapeutic indication (EMA)

Substitution treatment for opioid-drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.

Zubsolv Accord Healthcare S.L.U. · Authorised · authorised 10 Nov 2017 · ATC N07BC51

Therapeutic indication (EMA)

Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PMS-BUPRENORPHINE-NALOXONE	02424851	0.5 MG; 2 MG	TABLET · SUBLINGUAL	PHARMASCIENCE INC
PMS-BUPRENORPHINE-NALOXONE	02424878	2 MG; 8 MG	TABLET · SUBLINGUAL	PHARMASCIENCE INC
SUBOXONE	02295695	2 MG; 0.5 MG	TABLET · SUBLINGUAL	INDIVIOR UK LIMITED
SUBOXONE	02295709	2 MG; 8 MG	TABLET · SUBLINGUAL	INDIVIOR UK LIMITED
SUBOXONE	02468085	12 MG; 3 MG	TABLET · SUBLINGUAL	INDIVIOR UK LIMITED
SUBOXONE	02468093	16 MG; 4 MG	TABLET · SUBLINGUAL	INDIVIOR UK LIMITED
SUBOXONE	02502313	2 MG; 0.5 MG	FILM (SOLUBLE) · BUCCAL; SUBLINGUAL	INDIVIOR UK LIMITED
SUBOXONE	02502321	4 MG; 1 MG	FILM (SOLUBLE) · BUCCAL; SUBLINGUAL	INDIVIOR UK LIMITED
SUBOXONE	02502348	8 MG; 2 MG	FILM (SOLUBLE) · BUCCAL; SUBLINGUAL	INDIVIOR UK LIMITED
SUBOXONE	02502356	12 MG; 3 MG	FILM (SOLUBLE) · BUCCAL; SUBLINGUAL	INDIVIOR UK LIMITED
TEVA-BUPRENORPHINE/NALOXONE	02453908	0.5 MG; 2 MG	TABLET · SUBLINGUAL	TEVA CANADA LIMITED
TEVA-BUPRENORPHINE/NALOXONE	02453916	8 MG; 2 MG	TABLET · SUBLINGUAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	BUPRENORPHINE-NALOXONE 12-3 MG SL FILM	$4.48557	per EA	23 Sep 2026
US NADAC	BUPRENORPHINE-NALOXONE 2-0.5 MG SL FILM	$1.38554	per EA	23 Sep 2026
US NADAC	BUPRENORPHINE-NALOXONE 2-0.5 MG SL TABLET	$0.52138	per EA	23 Sep 2026
US NADAC	BUPRENORPHINE-NALOXONE 4-1 MG SL FILM	$2.57624	per EA	23 Sep 2026
US NADAC	BUPRENORPHINE-NALOXONE 8-2 MG SL FILM	$1.98226	per EA	23 Sep 2026
US NADAC	BUPRENORPHINE-NALOXONE 8-2 MG SL TABLET	$0.66282	per EA	23 Sep 2026
US NADAC	SUBOXONE 12 MG-3 MG SL FILM	$17.16317	per EA	23 Sep 2026
US NADAC	SUBOXONE 2 MG-0.5 MG SL FILM	$4.78523	per EA	23 Sep 2026
US NADAC	SUBOXONE 4 MG-1 MG SL FILM	$8.58442	per EA	23 Sep 2026
US NADAC	SUBOXONE 8 MG-2 MG SL FILM	$8.59221	per EA	23 Sep 2026
US NADAC	ZUBSOLV 0.7-0.18 MG TABLET SL	$5.26141	per EA	23 Sep 2026
US NADAC	ZUBSOLV 1.4-0.36 MG TABLET SL	$5.2646	per EA	23 Sep 2026
NHS Drug Tariff	Buprenorphine 1.4mg / Naloxone 360microgram sublingual tablets sugar free	£25.40	28 tablet	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.