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FDA ANDA · ANDA091149
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Sponsor: TEVA PHARMS USA
APPLICATION
ANDA091149
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-08
LATEST ACTION
2025-12-22
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE, NALOXONE HYDROCHLORIDE EQ 0.5MG BASE · TABLET · SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE, NALOXONE HYDROCHLORIDE EQ 2MG BASE · TABLET · SUBLINGUAL
Approval history
2025-12-22Labeling · Supplement 27 · standardAP
2025-02-21REMS · Supplement 26AP
2024-03-20REMS · Supplement 22AP
2023-12-15Labeling · Supplement 25 · standardAP
2023-06-26Labeling · Supplement 23 · standardAP
2023-06-26Labeling · Supplement 24 · standardAP
2022-12-16REMS · Supplement 21AP
2022-06-17Labeling · Supplement 20 · standardAP
2022-06-17Labeling · Supplement 18 · standardAP
2022-06-13Labeling · Supplement 16 · standardAP
2022-05-03REMS · Supplement 19AP
2021-03-04Labeling · Supplement 15 · standardAP
2019-10-07Labeling · Supplement 14 · standardAP
2018-10-31REMS · Supplement 13AP
2018-02-01Labeling · Supplement 12 · standardAP
2018-02-01Labeling · Supplement 11 · standardAP
2018-01-31Labeling · Supplement 10 · standardAP
2017-05-23REMS · Supplement 9AP
2016-12-16Labeling · Supplement 8 · standardAP
2016-12-16Labeling · Supplement 6 · standardAP
2016-07-07REMS · Supplement 3AP
2015-02-12REMS · Supplement 1AP
2015-02-05Labeling · Supplement 2 · 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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