APPLICATION
ANDA214930
TYPE
ANDA
ORIGINAL APPROVAL
2021-06-15
LATEST ACTION
2025-12-22
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE, NALOXONE HYDROCHLORIDE EQ 2MG BASE · TABLET · SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE, NALOXONE HYDROCHLORIDE EQ 0.5MG BASE · TABLET · SUBLINGUAL
Approval history
2025-12-22Labeling · Supplement 13 · standardAP
2025-02-21REMS · Supplement 12AP
2024-03-20REMS · Supplement 8AP
2023-12-15Labeling · Supplement 10 · standardAP
2023-05-25Labeling · Supplement 9 · standardAP
2023-03-27Labeling · Supplement 5 · standardAP
2022-12-16REMS · Supplement 7AP
2022-06-17Labeling · Supplement 4 · standardAP
2022-06-17Labeling · Supplement 1 · standardAP
2022-05-03REMS · Supplement 2AP
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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