APPLICATION
ANDA205299
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-14
LATEST ACTION
2025-02-21
ROUTE
BUCCAL, SUBLINGUAL, BUCCAL, SUBLINGUAL
DOSAGE FORM
FILM
MARKETING STATUS
Prescription
Products
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE, NALOXONE HYDROCHLORIDE EQ 2MG BASE · FILM · BUCCAL, SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE, NALOXONE HYDROCHLORIDE EQ 0.5MG BASE · FILM · BUCCAL, SUBLINGUAL
Approval history
2025-02-21REMS · Supplement 20AP
2024-03-20REMS · Supplement 15AP
2022-12-16REMS · Supplement 14AP
2022-12-06Labeling · Supplement 12 · standardAP
2022-05-03REMS · Supplement 9AP
2018-10-31REMS · Supplement 1AP
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.