Suboxone

Treats opioid dependence. NDA 22410, held by Indivior. Buprenorphine Hydrochloride; Naloxone Hydrochloride.

As of Nov 14, 2026, NDA 22410 (Suboxone), held by Indivior, was first approved by FDA on Aug 30, 2010, with 40 approved supplements and 0 published complete response letters.

First approved: Aug 30, 2010
Review: Standard
Supplements approved: 40
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 41 submissions below


Feb 13, 2017	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 22, 2015	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 28, 2014	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 28, 2014	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 30, 2010	Original applicationNew combination · Standard review	Approved	REMS Summary Review Review Label

Products

4 strengths and forms


SuboxoneEQ 2MG BASE;EQ 0.5MG BASE · film;buccal, sublingual	Buprenorphine Hydrochloride; Naloxone Hydrochloride	RxReference drug
SuboxoneEQ 8MG BASE;EQ 2MG BASE · film;buccal, sublingual	Buprenorphine Hydrochloride; Naloxone Hydrochloride	RxReference drug
SuboxoneEQ 4MG BASE;EQ 1MG BASE · film;buccal, sublingual	Buprenorphine Hydrochloride; Naloxone Hydrochloride	RxReference drug
SuboxoneEQ 12MG BASE;EQ 3MG BASE · film;buccal, sublingual	Buprenorphine Hydrochloride; Naloxone Hydrochloride	RxReference drug

All 41 submissions, including labeling and manufacturing supplements


Aug 14, 2026	Supplement 58REMS	Approved	Letter
Dec 22, 2025	Supplement 57Labeling · Standard review	Approved	Letter Label
May 19, 2025	Supplement 56Labeling · Standard review	Approved	Letter Label
Feb 21, 2025	Supplement 55REMS	Approved	Letter
Mar 20, 2024	Supplement 50REMS	Approved	Letter
Dec 15, 2023	Supplement 52Labeling · Standard review	Approved	Label
Mar 13, 2023	Supplement 49Labeling · Standard review	Approved	Letter Label
Dec 16, 2022	Supplement 48REMS	Approved	Letter
Jun 17, 2022	Supplement 47Labeling · Standard review	Approved	Letter Label Medication Guide
Jun 17, 2022	Supplement 46Labeling · Standard review	Approved	Letter Label
May 3, 2022	Supplement 45REMS	Approved	Letter
Nov 19, 2021	Supplement 44REMS	Approved	Letter
Mar 4, 2021	Supplement 42Labeling · Standard review	Approved	Letter Label Medication Guide
Mar 2, 2020	Supplement 39REMS	Approved	Letter
Oct 31, 2019	Supplement 34Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 38Labeling · Standard review	Approved	Letter Label
Oct 26, 2018	Supplement 35REMS	Approved	Letter
Jun 11, 2018	Supplement 33REMS	Approved	Medication Guide Label Letter
Feb 1, 2018	Supplement 31Labeling · Standard review	Approved	Letter Label
Sep 19, 2017	Supplement 30REMS	Approved	Letter
Sep 19, 2017	Supplement 29REMS · Standard review	Approved	None posted
Feb 13, 2017	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 12, 2017	Supplement 28Manufacturing · Standard review	Approved	None posted
Dec 16, 2016	Supplement 27Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 26Labeling · Standard review	Approved	Label Letter
Jul 7, 2016	Supplement 25REMS	Approved	Letter
Apr 15, 2016	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 22, 2015	Supplement 22REMS	Approved	Label Letter
Sep 22, 2015	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 23, 2015	Supplement 21Manufacturing · Standard review	Approved	None posted
Aug 12, 2014	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 5, 2014	Supplement 16Manufacturing · Standard review	Approved	Review
Apr 28, 2014	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 28, 2014	Supplement 17Labeling	Approved	Letter Label
Apr 28, 2014	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 12, 2014	Supplement 14Manufacturing · Standard review	Approved	Review
Nov 22, 2013	Supplement 15Labeling · Standard review	Approved	Label Letter
Aug 8, 2013	Supplement 11Manufacturing · Standard review	Approved	Review
Aug 10, 2012	Supplement 7Manufacturing · Standard review	Approved	Review Label
Aug 10, 2012	Supplement 6Manufacturing · Standard review	Approved	Review Label
Aug 30, 2010	Original applicationNew combination · Standard review	Approved	REMS Summary Review Review Label

Identifiers

Application: NDA 22410
Drugs@FDA: Overview at FDA
Company: Indivior

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters