Subutex

NDA 20732, held by Indivior. Buprenorphine Hydrochloride.

As of Nov 13, 2026, NDA 20732 (Subutex), held by Indivior, was first approved by FDA on Oct 8, 2002, with 22 approved supplements and 0 published complete response letters.

First approved: Oct 8, 2002
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Oct 8, 2002	Original applicationNew dosage form · Standard review	Approved	Other Review Letter Label

Products

2 strengths and forms


SubutexEQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;sublingual	Buprenorphine Hydrochloride	DiscontinuedReference drug
SubutexEQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;sublingual	Buprenorphine Hydrochloride	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Jun 17, 2022	Supplement 27Labeling · Standard review	Approved	Letter Label
Jun 17, 2022	Supplement 28Labeling · Standard review	Approved	Letter Label Medication Guide
May 3, 2022	Supplement 26REMS	Approved	Letter
Nov 19, 2021	Supplement 25REMS	Approved	Letter
Mar 4, 2021	Supplement 24Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 2, 2020	Supplement 23REMS	Approved	Letter
Oct 31, 2019	Supplement 20Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 22Labeling · Standard review	Approved	Label Letter
Oct 26, 2018	Supplement 21REMS	Approved	Letter
Jun 11, 2018	Supplement 19REMS	Approved	Label Letter
Feb 1, 2018	Supplement 18Labeling · Standard review	Approved	Letter Label
Sep 19, 2017	Supplement 17REMS	Approved	Letter
Sep 7, 2017	Supplement 16Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 14Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 15Labeling · Standard review	Approved	Label Letter
Jul 7, 2016	Supplement 13REMS	Approved	Letter
Sep 22, 2015	Supplement 12REMS	Approved	Letter
Dec 11, 2014	Supplement 10Labeling · Standard review	Approved	Label Letter
Aug 8, 2013	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 22, 2011	Supplement 6REMS	Approved	Letter Label
Dec 22, 2011	Supplement 7Labeling	Approved	Letter Label
Oct 4, 2006	Supplement 2Labeling · Standard review	Approved	Letter
Oct 8, 2002	Original applicationNew dosage form · Standard review	Approved	Other Review Letter Label

Identifiers

Application: NDA 20732
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