APPLICATION
ANDA078633
TYPE
ANDA
ORIGINAL APPROVAL
2009-10-08
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 37 · standardAP
2025-02-21REMS · Supplement 36AP
2024-03-20REMS · Supplement 30AP
2023-12-15Labeling · Supplement 33 · standardAP
2023-10-18Labeling · Supplement 31 · standardAP
2022-12-16REMS · Supplement 29AP
2022-06-17Labeling · Supplement 28 · standardAP
2022-06-17Labeling · Supplement 26 · standardAP
2022-05-03REMS · Supplement 27AP
2021-11-24Labeling · Supplement 24 · standardAP
2021-03-04Labeling · Supplement 21 · standardAP
2021-02-08Labeling · Supplement 20 · standardAP
2019-10-07Labeling · Supplement 18 · standardAP
2018-10-31REMS · Supplement 16AP
2018-02-01Labeling · Supplement 15 · standardAP
2017-05-23REMS · Supplement 13AP
2016-12-16Labeling · Supplement 12 · standardAP
2016-12-16Labeling · Supplement 11 · standardAP
2016-07-07REMS · Supplement 10AP
2015-02-12REMS · Supplement 6AP
2015-02-04Labeling · Supplement 7 · standardAP
2013-09-04REMS · Supplement 5AP
2013-02-22Labeling · Supplement 4 · standardAP
2013-02-21Labeling · Supplement 3 · 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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