APPLICATION
ANDA090279
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-10
LATEST ACTION
2026-07-10
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUPRENORPHINE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 12MG BASE · TABLET · SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE · TABLET · SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 4MG BASE · TABLET · SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE · TABLET · SUBLINGUAL
Approval history
2026-01-02Labeling · Supplement 29 · standardAP
2025-02-21REMS · Supplement 25AP
2024-03-20REMS · Supplement 21AP
2023-12-15Labeling · Supplement 23 · standardAP
2023-06-26Labeling · Supplement 18 · standardAP
2023-06-26Labeling · Supplement 22 · standardAP
2022-12-16REMS · Supplement 19AP
2022-06-17Labeling · Supplement 17 · standardAP
2022-06-17Labeling · Supplement 13 · standardAP
2022-06-13Labeling · Supplement 12 · standardAP
2022-05-03REMS · Supplement 14AP
2021-03-04Labeling · Supplement 11 · standardAP
2019-10-09Labeling · Supplement 10 · standardAP
2018-10-31REMS · Supplement 9AP
2018-02-01Labeling · Supplement 8 · standardAP
2017-05-23REMS · Supplement 7AP
2016-12-16Labeling · Supplement 6 · standardAP
2016-12-16Labeling · Supplement 5 · standardAP
2016-07-07REMS · Supplement 4AP
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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