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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091459
Company: ENDO OPERATIONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 150MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
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
06/09/2011 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
12/05/2023 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/05/2023 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/05/2023 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

12/05/2023 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

04/28/2017 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/20/2014 SUPPL-8 Labeling-Medication Guide

Label is not available on this site.

01/31/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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