Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076465
Company: HERITAGE PHARMA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/11/2006 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-19 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/21/2015 SUPPL-18 Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

11/28/2008 SUPPL-13 Labeling

Label is not available on this site.

07/16/2008 SUPPL-12 Labeling

Label is not available on this site.

06/11/2010 SUPPL-9 Labeling

Label is not available on this site.

01/11/2008 SUPPL-7 Labeling

Label is not available on this site.

01/11/2008 SUPPL-6 Labeling

Label is not available on this site.

03/28/2007 SUPPL-3 Labeling

Label is not available on this site.

03/28/2007 SUPPL-2 Labeling

Label is not available on this site.

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