Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201514
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARMODAFINIL ARMODAFINIL 50MG TABLET; ORAL None (Tentative Approval) None No No
ARMODAFINIL ARMODAFINIL 150MG TABLET;ORAL None (Tentative Approval) None No No
ARMODAFINIL ARMODAFINIL 250MG TABLET;ORAL None (Tentative Approval) 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
11/25/2014 ORIG-1 Tentative Approval

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