Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077977
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Discontinued None No No
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Discontinued None No No
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Discontinued None No No
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Discontinued None No No
SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 200MG BASE 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
02/06/2007 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
02/21/2020 SUPPL-15 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/21/2020 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/21/2020 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/23/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

12/12/2014 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/12/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

09/29/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/30/2009 SUPPL-7 Labeling

Label is not available on this site.

03/23/2009 SUPPL-6 Labeling

Label is not available on this site.

03/23/2009 SUPPL-4 Labeling

Label is not available on this site.

09/15/2008 SUPPL-3 Labeling

Label is not available on this site.

01/09/2008 SUPPL-2 Labeling

Label is not available on this site.

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