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Abbreviated New Drug Application (ANDA): 075491
Company: AUROBINDO PHARMA USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET;ORAL Discontinued None No No
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET;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
04/17/2000 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75491ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075491_bupropion_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/18/2022 SUPPL-38 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/18/2022 SUPPL-37 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/18/2022 SUPPL-36 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/18/2022 SUPPL-35 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/18/2022 SUPPL-33 Labeling-Package Insert

Label is not available on this site.
05/22/2015 SUPPL-31 Labeling-Medication Guide

Label is not available on this site.
05/22/2015 SUPPL-30 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/14/2014 SUPPL-28 Labeling-Package Insert

Label is not available on this site.
02/07/2014 SUPPL-27 Labeling-Package Insert

Label is not available on this site.
02/07/2014 SUPPL-26 Labeling-Package Insert

Label is not available on this site.
04/22/2010 SUPPL-24 REMS-Proposal

Label is not available on this site.
12/10/2009 SUPPL-23 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
01/26/2009 SUPPL-22 Labeling

Label is not available on this site.
09/08/2008 SUPPL-16 Labeling

Label is not available on this site.
01/16/2008 SUPPL-14 Labeling

Label is not available on this site.
01/16/2008 SUPPL-13 Labeling

Label is not available on this site.
05/01/2007 SUPPL-12 Labeling

Label is not available on this site.
02/06/2006 SUPPL-7 Labeling

Label is not available on this site.
04/08/2005 SUPPL-6 Labeling

Label is not available on this site.
02/06/2004 SUPPL-5 Labeling

Label is not available on this site.
08/26/2002 SUPPL-2 Labeling

Label is not available on this site.
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