Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076711
Company: IMPAX LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 200MG 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
12/03/2004 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
01/04/2021 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

01/04/2021 SUPPL-39 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/04/2021 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

01/04/2021 SUPPL-31 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/04/2021 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

09/29/2015 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

02/21/2012 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

02/21/2012 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

08/18/2010 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/08/2010 SUPPL-11 REMS-Proposal

Label is not available on this site.

01/27/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/16/2008 SUPPL-7 Labeling

Label is not available on this site.

10/05/2006 SUPPL-5 Labeling

Label is not available on this site.

02/14/2006 SUPPL-3 Labeling

Label is not available on this site.

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