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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077415
Company: IMPAX LABS
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
12/15/2006 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077415TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077415.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/07/2020 SUPPL-36 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/26/2017 SUPPL-33 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/26/2017 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/26/2017 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

12/01/2014 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

03/29/2012 SUPPL-18 Labeling-Package Insert Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077415Orig1s018.pdf
08/30/2011 SUPPL-17 Labeling-Package Insert Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/077415Orig1s017.pdf
05/13/2010 SUPPL-15 REMS-Proposal

Label is not available on this site.

01/22/2010 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

12/15/2009 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

11/26/2008 SUPPL-7 Labeling

Label is not available on this site.

11/26/2008 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/2008 SUPPL-5 Labeling

Label is not available on this site.

09/17/2007 SUPPL-3 Labeling

Label is not available on this site.

09/17/2007 SUPPL-2 Labeling

Label is not available on this site.

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