APPLICATION
ANDA207607
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 12MG BASE, NALOXONE HYDROCHLORIDE EQ 3MG BASE · FILM · BUCCAL, SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE, NALOXONE HYDROCHLORIDE EQ 2MG BASE · FILM · BUCCAL, SUBLINGUAL
Approval history
2025-02-21REMS · Supplement 25AP
2024-06-12Labeling · Supplement 18 · standardAP
2024-06-12Labeling · Supplement 14 · standardAP
2024-06-12Labeling · Supplement 10 · standardAP
2024-06-12Labeling · Supplement 6 · standardAP
2024-06-12Labeling · Supplement 23 · standardAP
2024-06-12Labeling · Supplement 7 · standardAP
2024-03-20REMS · Supplement 17AP
2022-12-16REMS · Supplement 15AP
2022-05-03REMS · Supplement 12AP
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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