Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076671
Company: MYLAN
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
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
12/13/2019 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/21/2012 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

06/25/2010 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/25/2009 SUPPL-6 Labeling

Label is not available on this site.

01/06/2009 SUPPL-5 Labeling

Label is not available on this site.

07/16/2008 SUPPL-4 Labeling

Label is not available on this site.

01/09/2008 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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