Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076630
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMOTRIGINE LAMOTRIGINE 5MG TABLET, CHEWABLE;ORAL Discontinued None No No
LAMOTRIGINE LAMOTRIGINE 25MG TABLET, CHEWABLE;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
01/22/2009 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
03/19/2012 SUPPL-5 REMS-Modified, Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/25/2011 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Modified

Label is not available on this site.

04/27/2010 SUPPL-1 REMS-Proposal, Labeling-Container/Carton Labels

Label is not available on this site.

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