APPLICATION
ANDA219850
TYPE
ANDA
ORIGINAL APPROVAL
2026-01-21
LATEST ACTION
2026-01-21
ROUTE
BUCCAL, SUBLINGUAL, BUCCAL, SUBLINGUAL
DOSAGE FORM
FILM
MARKETING STATUS
Prescription
Products
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE, NALOXONE HYDROCHLORIDE EQ 0.5MG BASE · FILM · BUCCAL, SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 12MG BASE, NALOXONE HYDROCHLORIDE EQ 3MG BASE · FILM · BUCCAL, SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 4MG BASE, NALOXONE HYDROCHLORIDE EQ 1MG BASE · FILM · BUCCAL, SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE, NALOXONE HYDROCHLORIDE EQ 2MG BASE · FILM · BUCCAL, SUBLINGUAL
Approval history
2026-01-21UNKNOWN · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.