← FDA DRUG APPROVALS

FDA NDA · NDA022410

SUBOXONE

buprenorphine hydrochloride, naloxone hydrochloride

Sponsor: INDIVIOR

APPLICATION
NDA022410
TYPE
NDA
ORIGINAL APPROVAL
2010-08-30
LATEST ACTION
2025-12-22
ROUTE
BUCCAL, SUBLINGUAL, BUCCAL, SUBLINGUAL
DOSAGE FORM
FILM
MARKETING STATUS
Prescription

Products

SUBOXONE · ReferencePrescription
BUPRENORPHINE HYDROCHLORIDE EQ 12MG BASE, NALOXONE HYDROCHLORIDE EQ 3MG BASE · FILM · BUCCAL, SUBLINGUAL
SUBOXONE · ReferencePrescription
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE, NALOXONE HYDROCHLORIDE EQ 2MG BASE · FILM · BUCCAL, SUBLINGUAL
SUBOXONE · ReferencePrescription
BUPRENORPHINE HYDROCHLORIDE EQ 4MG BASE, NALOXONE HYDROCHLORIDE EQ 1MG BASE · FILM · BUCCAL, SUBLINGUAL
SUBOXONE · ReferencePrescription
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE, NALOXONE HYDROCHLORIDE EQ 0.5MG BASE · FILM · BUCCAL, SUBLINGUAL

Approval history

2025-12-22Labeling · Supplement 57 · standard — Label ↗AP
2025-05-19Labeling · Supplement 56 · standard — Letter ↗AP
2025-02-21REMS · Supplement 55 — Letter ↗AP
2024-03-20REMS · Supplement 50 — Letter ↗AP
2023-12-15Labeling · Supplement 52 · standard — Label ↗AP
2023-03-13Labeling · Supplement 49 · standard — Letter ↗AP
2022-12-16REMS · Supplement 48 — Letter ↗AP
2022-06-17Labeling · Supplement 47 · standard — Letter ↗AP
2022-06-17Labeling · Supplement 46 · standard — Letter ↗AP
2022-05-03REMS · Supplement 45 — Letter ↗AP
2021-11-19REMS · Supplement 44 — Letter ↗AP
2021-03-04Labeling · Supplement 42 · standard — Letter ↗AP
2020-03-02REMS · Supplement 39 — Letter ↗AP
2019-10-31Labeling · Supplement 34 · standard — Label ↗AP
2019-10-07Labeling · Supplement 38 · standard — Letter ↗AP
2018-10-26REMS · Supplement 35 — Letter ↗AP
2018-06-11REMS · Supplement 33 — Letter ↗AP
2018-02-01Labeling · Supplement 31 · standard — Label ↗AP
2017-09-19REMS · Supplement 30 — Letter ↗AP
2017-09-19REMS · Supplement 29 · standardAP
2017-02-13Efficacy · Supplement 23 · standard — Letter ↗AP
2017-01-12Manufacturing (CMC) · Supplement 28 · standardAP
2016-12-16Labeling · Supplement 26 · standard — Label ↗AP
2016-12-16Labeling · Supplement 27 · standard — Label ↗AP
2016-07-07REMS · Supplement 25 — Letter ↗AP
2016-04-15Manufacturing (CMC) · Supplement 24 · standardAP
2015-09-22REMS · Supplement 22 — Letter ↗AP
2015-09-22Efficacy · Supplement 20 · standard — Label ↗AP
2015-06-23Manufacturing (CMC) · Supplement 21 · standardAP
2014-08-12Manufacturing (CMC) · Supplement 19 · standardAP
2014-06-05Manufacturing (CMC) · Supplement 16 · standard — Review ↗AP
2014-04-28Efficacy · Supplement 18 · standard — Letter ↗AP
2014-04-28Efficacy · Supplement 4 · standard — Label ↗AP
2014-04-28Labeling · Supplement 17 · unknown — Label ↗AP
2014-03-12Manufacturing (CMC) · Supplement 14 · standard — Review ↗AP
2013-11-22Labeling · Supplement 15 · standard — Letter ↗AP
2013-08-08Manufacturing (CMC) · Supplement 11 · standard — Review ↗AP
2012-08-10Manufacturing (CMC) · Supplement 6 · standard — Review ↗AP
2012-08-10Manufacturing (CMC) · Supplement 7 · standard — Review ↗AP
2010-08-30Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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