Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078101
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVETIRACETAM LEVETIRACETAM 250MG TABLET;ORAL Discontinued None No No
LEVETIRACETAM LEVETIRACETAM 500MG TABLET;ORAL Discontinued None No No
LEVETIRACETAM LEVETIRACETAM 750MG TABLET;ORAL Discontinued None No No
LEVETIRACETAM LEVETIRACETAM 1GM 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
01/15/2009 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
09/18/2014 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/18/2014 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2014 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/22/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

10/27/2010 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/27/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

10/27/2010 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

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