Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078645
Company: SANDOZ
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
01/27/2009 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
02/18/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

09/29/2011 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

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