APPLICATION
ANDA090622
TYPE
ANDA
ORIGINAL APPROVAL
2010-09-24
LATEST ACTION
2025-12-22
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BUPRENORPHINE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE · TABLET · SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDEPrescription
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE · TABLET · SUBLINGUAL
Approval history
2025-12-22Labeling · Supplement 45 · standardAP
2025-02-21REMS · Supplement 44AP
2024-03-20REMS · Supplement 40AP
2023-12-15Labeling · Supplement 42 · standardAP
2023-06-26Labeling · Supplement 41 · standardAP
2022-12-16REMS · Supplement 37AP
2022-06-17Labeling · Supplement 36 · standardAP
2022-06-17Labeling · Supplement 34 · standardAP
2022-06-16Labeling · Supplement 33 · standardAP
2022-05-03REMS · Supplement 35AP
2021-03-04Labeling · Supplement 32 · standardAP
2019-10-09Labeling · Supplement 30 · standardAP
2018-10-31REMS · Supplement 26AP
2018-02-01Labeling · Supplement 25 · standardAP
2017-05-23REMS · Supplement 21AP
2016-12-16Labeling · Supplement 19 · standardAP
2016-12-16Labeling · Supplement 18 · standardAP
2016-07-07REMS · Supplement 17AP
2015-02-12REMS · Supplement 12AP
2015-02-04Labeling · Supplement 13 · standardAP
2015-02-04Labeling · Supplement 6 · standardAP
2013-09-04REMS · Supplement 7AP
2013-02-22Labeling · Supplement 5 · standardAP
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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