APPLICATION
ANDA205806
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-14
LATEST ACTION
2026-04-15
ROUTE
BUCCAL, SUBLINGUAL, BUCCAL, SUBLINGUAL
DOSAGE FORM
FILM
MARKETING STATUS
Prescription
Products
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
Approval history
2026-04-15Labeling · Supplement 17 · standardAP
2026-04-15Labeling · Supplement 21 · standardAP
2026-04-15Labeling · Supplement 4 · standardAP
2026-04-15Labeling · Supplement 18 · standardAP
2026-04-15Labeling · Supplement 22 · standardAP
2026-04-15Labeling · Supplement 12 · standardAP
2026-04-15Labeling · Supplement 7 · standardAP
2025-02-21REMS · Supplement 19AP
2024-03-20REMS · Supplement 14AP
2022-12-16REMS · Supplement 13AP
2022-12-06Labeling · Supplement 11 · unknownAP
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.
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