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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091149
Company: TEVA PHARMS USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE TABLET;SUBLINGUAL Discontinued None No No
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE TABLET;SUBLINGUAL Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/08/2014 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2025 SUPPL-27 Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
02/21/2025 SUPPL-26 REMS - MODIFIED - D-N-A

Label is not available on this site.
12/15/2023 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
06/26/2023 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
06/26/2023 SUPPL-23 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
03/20/2024 SUPPL-22 REMS - MODIFIED - D-N-A

Label is not available on this site.
12/16/2022 SUPPL-21 REMS - MODIFIED - D-N-A

Label is not available on this site.
06/17/2022 SUPPL-20 Labeling-Package Insert

Label is not available on this site.
05/03/2022 SUPPL-19 REMS - MODIFIED - D-N-A

Label is not available on this site.
06/17/2022 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
06/13/2022 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
03/04/2021 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/07/2019 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/31/2018 SUPPL-13 REMS - MODIFIED - D-N-A

Label is not available on this site.
02/01/2018 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
02/01/2018 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
01/31/2018 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
05/23/2017 SUPPL-9 REMS-Modified

Label is not available on this site.
12/16/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
12/16/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
07/07/2016 SUPPL-3 REMS-Modified

Label is not available on this site.
02/05/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
02/12/2015 SUPPL-1 REMS-Modified

Label is not available on this site.
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