Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201066
Company: MYLAN
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
03/06/2015 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/27/2021 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/31/2018 SUPPL-9 REMS - MODIFIED - D-N-A

Label is not available on this site.

02/01/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/31/2018 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/31/2018 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/23/2017 SUPPL-5 REMS-Modified

Label is not available on this site.

12/16/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/07/2016 SUPPL-2 REMS-Proposal

Label is not available on this site.

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