← FDA DRUG APPROVALS

FDA NDA · NDA204242

ZUBSOLV

buprenorphine hydrochloride and naloxone hydrochloride

Sponsor: EDENBRIDGE PHARMS

APPLICATION
NDA204242
TYPE
NDA
ORIGINAL APPROVAL
2013-07-03
LATEST ACTION
2025-12-22
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ZUBSOLV · ReferencePrescription
BUPRENORPHINE HYDROCHLORIDE EQ 1.4MG BASE, NALOXONE HYDROCHLORIDE EQ 0.36MG BASE · TABLET · SUBLINGUAL
ZUBSOLV · ReferencePrescription
BUPRENORPHINE HYDROCHLORIDE EQ 0.7MG BASE, NALOXONE HYDROCHLORIDE EQ 0.18MG BASE · TABLET · SUBLINGUAL
ZUBSOLV · ReferencePrescription
BUPRENORPHINE HYDROCHLORIDE EQ 11.4MG BASE, NALOXONE HYDROCHLORIDE EQ 2.9MG BASE · TABLET · SUBLINGUAL
ZUBSOLV · ReferencePrescription
BUPRENORPHINE HYDROCHLORIDE EQ 5.7MG BASE, NALOXONE HYDROCHLORIDE EQ 1.4MG BASE · TABLET · SUBLINGUAL
ZUBSOLV · ReferencePrescription
BUPRENORPHINE HYDROCHLORIDE EQ 2.9MG BASE, NALOXONE HYDROCHLORIDE EQ 0.71MG BASE · TABLET · SUBLINGUAL
ZUBSOLV · ReferencePrescription
BUPRENORPHINE HYDROCHLORIDE EQ 8.6MG BASE, NALOXONE HYDROCHLORIDE EQ 2.1MG BASE · TABLET · SUBLINGUAL

Approval history

2025-12-22Labeling · Supplement 32 · standard — Letter ↗AP
2025-05-19Labeling · Supplement 31 · standard — Letter ↗AP
2025-02-21REMS · Supplement 29 — Letter ↗AP
2024-03-20REMS · Supplement 26 — Letter ↗AP
2023-12-15Labeling · Supplement 27 · standard — Label ↗AP
2023-03-23Labeling · Supplement 25 · standard — Label ↗AP
2022-12-16REMS · Supplement 24 — Letter ↗AP
2022-06-17Labeling · Supplement 23 · standard — Letter ↗AP
2022-06-17Labeling · Supplement 21 · standard — Letter ↗AP
2022-05-03REMS · Supplement 22 — Letter ↗AP
2021-03-04Labeling · Supplement 19 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 17 · standard — Letter ↗AP
2018-10-31REMS · Supplement 15 — Letter ↗AP
2018-02-01Labeling · Supplement 14 · standard — Label ↗AP
2017-09-08Labeling · Supplement 11 · standard — Label ↗AP
2017-05-23REMS · Supplement 12 — Letter ↗AP
2016-12-16Labeling · Supplement 9 · standard — Letter ↗AP
2016-10-04Efficacy · Supplement 7 · standard — Letter ↗AP
2016-07-07REMS · Supplement 8 — Letter ↗AP
2015-08-10Efficacy · Supplement 4 · standard — Label ↗AP
2015-06-04Manufacturing (CMC) · Supplement 6 · standard — Label ↗AP
2015-02-12REMS · Supplement 5 — Letter ↗AP
2014-12-11Manufacturing (CMC) · Supplement 3 · standard — Letter ↗AP
2014-01-14Manufacturing (CMC) · Supplement 1 · standardAP
2013-09-04REMS · Supplement 2 — Letter ↗AP
2013-07-03Type 5 - New Formulation or New Manufacturer · 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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