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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077284
Company: ENDO OPERATIONS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL 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
12/14/2006 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/077284lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077284s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077284Orig1Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/02/2023 SUPPL-54 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/02/2023 SUPPL-52 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/02/2023 SUPPL-47 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
06/12/2019 SUPPL-42 Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.
08/25/2017 SUPPL-39 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/25/2017 SUPPL-36 Labeling-Container/Carton Labels

Label is not available on this site.
08/25/2017 SUPPL-33 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/13/2014 SUPPL-30 Labeling-Package Insert

Label is not available on this site.
10/31/2011 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
08/30/2011 SUPPL-22 Labeling-Package Insert

Label is not available on this site.
11/19/2010 SUPPL-20 REMS-Proposal

Label is not available on this site.
01/25/2011 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
12/15/2009 SUPPL-17 Labeling-Package Insert

Label is not available on this site.
01/20/2011 SUPPL-11 Labeling

Label is not available on this site.
09/17/2007 SUPPL-8 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/14/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/077284lbl.pdf
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