Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078310
Company: PHARMASCIENCE INC
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
02/04/2009 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
12/07/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

05/21/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

09/29/2011 SUPPL-1 REMS-Proposal, Labeling-Medication Guide

Label is not available on this site.

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