Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078582
Company: ACI HEALTHCARE LTD
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/2009/078582s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/18/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/09/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/09/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

02/27/2013 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

12/09/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/17/2011 SUPPL-4 REMS-Modified

Label is not available on this site.

09/21/2010 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/15/2009 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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