Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078134
Company: HIKMA PHARMS
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
04/19/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078134Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/14/2014 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/14/2014 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/14/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/17/2012 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/29/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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