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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090360
Company: BARR

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET;SUBLINGUAL Discontinued None No No
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 8MG 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
05/07/2010 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
12/15/2023 SUPPL-28 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
06/07/2023 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
06/07/2023 SUPPL-26 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
03/20/2024 SUPPL-25 REMS - MODIFIED - D-N-A

Label is not available on this site.
12/16/2022 SUPPL-24 REMS - MODIFIED - D-N-A

Label is not available on this site.
06/17/2023 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
05/03/2022 SUPPL-22 REMS - MODIFIED - D-N-A

Label is not available on this site.
06/17/2023 SUPPL-21 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
06/14/2022 SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
03/04/2021 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/08/2019 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/31/2018 SUPPL-16 REMS - MODIFIED - D-N-A

Label is not available on this site.
02/01/2018 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
05/23/2017 SUPPL-14 REMS-Modified

Label is not available on this site.
03/22/2017 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

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

Label is not available on this site.
12/16/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
07/07/2016 SUPPL-10 REMS-Modified

Label is not available on this site.
02/04/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
02/12/2015 SUPPL-7 REMS-Modified

Label is not available on this site.
09/04/2013 SUPPL-6 REMS-Modified

Label is not available on this site.
02/22/2013 SUPPL-4 REMS, Labeling-Package Insert

Label is not available on this site.
02/04/2015 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
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