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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200695
Company: SUN PHARM
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/18/2014 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/23/2017 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

08/23/2017 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/27/2015 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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