APPLICATION
ANDA090360
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-07
LATEST ACTION
2025-12-22
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BUPRENORPHINE HYDROCHLORIDEDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE · TABLET · SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDEDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE · TABLET · SUBLINGUAL
Approval history
2025-12-22Labeling · Supplement 30 · standardAP
2025-02-21REMS · Supplement 29AP
2024-03-20REMS · Supplement 25AP
2023-12-15Labeling · Supplement 28 · standardAP
2023-06-17Labeling · Supplement 21 · standardAP
2023-06-17Labeling · Supplement 23 · standardAP
2023-06-07Labeling · Supplement 26 · standardAP
2023-06-07Labeling · Supplement 27 · standardAP
2022-12-16REMS · Supplement 24AP
2022-06-14Labeling · Supplement 19 · standardAP
2022-05-03REMS · Supplement 22AP
2021-03-04Labeling · Supplement 18 · standardAP
2019-10-08Labeling · Supplement 17 · standardAP
2018-10-31REMS · Supplement 16AP
2018-02-01Labeling · Supplement 15 · standardAP
2017-05-23REMS · Supplement 14AP
2017-03-22Labeling · Supplement 13 · standardAP
2016-12-16Labeling · Supplement 11 · standardAP
2016-12-16Labeling · Supplement 12 · standardAP
2016-07-07REMS · Supplement 10AP
2015-02-12REMS · Supplement 7AP
2015-02-04Labeling · Supplement 8 · standardAP
2015-02-04Labeling · Supplement 2AP
2013-09-04REMS · Supplement 6AP
2013-02-22Labeling · Supplement 4 · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.