Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079107
Company: ANDA REPOSITORY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVETIRACETAM LEVETIRACETAM 100MG/ML SOLUTION;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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079107s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/03/2014 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

11/03/2014 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

11/03/2014 SUPPL-12 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

10/26/2012 SUPPL-11 Labeling-Package Insert, REMS

Label is not available on this site.

11/03/2014 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/29/2010 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/20/2009 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide, REMS-Proposal

Label is not available on this site.

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