Sublocade

Treats moderate to severe opioid use disorder. NDA 209819, held by Indivior. Buprenorphine.

As of Nov 13, 2026, NDA 209819 (Sublocade), held by Indivior, was first approved by FDA on Nov 30, 2017, with 19 approved supplements and 0 published complete response letters.

First approved: Nov 30, 2017
Review: Priority
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE 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 20 submissions below


Feb 21, 2025	Supplement 31Efficacy (new indication or use) · Priority review	Approved	Label Letter Medication Guide
Nov 30, 2017	Original applicationNew dosage form · Priority review	Approved	REMS Review Summary Review Label

Products

2 strengths and forms


Sublocade100MG/0.5ML (100MG/0.5ML) · solution, extended release;subcutaneous	Buprenorphine	RxReference drug
Sublocade300MG/1.5ML (200MG/ML) · solution, extended release;subcutaneous	Buprenorphine	RxReference drug

All 20 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 37Labeling · Standard review	Approved	Label Letter
Apr 11, 2025	Supplement 34REMS	Approved	Letter
Feb 21, 2025	Supplement 31Efficacy (new indication or use) · Priority review	Approved	Label Letter Medication Guide
Apr 19, 2024	Supplement 29REMS	Approved	Letter
Dec 15, 2023	Supplement 28Labeling · Standard review	Approved	Letter Label
Sep 12, 2023	Supplement 26Manufacturing	Approved	Letter Label
Jul 3, 2023	Supplement 24REMS	Approved	Letter
Mar 13, 2023	Supplement 22Labeling · Standard review	Approved	Letter Label
Jan 6, 2023	Supplement 21REMS	Approved	Letter
Aug 23, 2022	Supplement 10Labeling · Standard review	Approved	Label Letter
Jun 17, 2022	Supplement 20Labeling · Standard review	Approved	Letter Label
Sep 22, 2021	Supplement 19REMS	Approved	Letter
Jun 17, 2021	Supplement 18Labeling · Standard review	Approved	Letter Label Medication Guide
May 11, 2021	Supplement 15Labeling · Standard review	Approved	Label Letter
Mar 4, 2021	Supplement 17Labeling · Standard review	Approved	Label
Jun 15, 2020	Supplement 16REMS	Approved	Letter
Feb 4, 2020	Supplement 12Labeling · Standard review	Approved	Label Letter
Oct 7, 2019	Supplement 9Labeling · Standard review	Approved	Label Letter
Mar 5, 2018	Supplement 1Labeling · Standard review	Approved	Letter Label
Nov 30, 2017	Original applicationNew dosage form · Priority review	Approved	REMS Review Summary Review Label

Identifiers

Application: NDA 209819
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