APPLICATION
ANDA207276
TYPE
ANDA
ORIGINAL APPROVAL
2017-03-27
LATEST ACTION
2025-12-22
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUPRENORPHINE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE · TABLET · SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE · TABLET · SUBLINGUAL
Approval history
2025-12-22Labeling · Supplement 22 · standardAP
2025-02-21REMS · Supplement 20AP
2024-03-20REMS · Supplement 15AP
2023-12-15Labeling · Supplement 17 · standardAP
2023-06-22Labeling · Supplement 16 · standardAP
2022-12-16REMS · Supplement 14AP
2022-06-17Labeling · Supplement 13 · standardAP
2022-06-17Labeling · Supplement 11 · standardAP
2022-06-13Labeling · Supplement 10 · standardAP
2022-05-03REMS · Supplement 12AP
2021-03-04Labeling · Supplement 8 · standardAP
2018-10-31REMS · Supplement 4AP
2018-02-01Labeling · Supplement 3 · standardAP
2017-05-23REMS · 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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