Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076388
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMOTRIGINE LAMOTRIGINE 25MG TABLET;ORAL Discontinued None No No
LAMOTRIGINE LAMOTRIGINE 100MG TABLET;ORAL Discontinued None No No
LAMOTRIGINE LAMOTRIGINE 150MG TABLET;ORAL Discontinued None No No
LAMOTRIGINE LAMOTRIGINE 200MG 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
08/30/2006 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076388s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/076388Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

09/30/2016 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/30/2016 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

09/26/2014 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

09/26/2014 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

09/26/2014 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

04/30/2012 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

04/30/2012 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/29/2011 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/28/2010 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

04/28/2010 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

12/20/2009 SUPPL-12 Labeling

Label is not available on this site.

03/14/2008 SUPPL-6 Labeling

Label is not available on this site.

10/31/2007 SUPPL-1 Labeling

Label is not available on this site.

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