Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078797
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVETIRACETAM LEVETIRACETAM 1GM TABLET;ORAL Discontinued None No No
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
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
02/10/2016 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

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