Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205057
Company: ROXANE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAPENTADOL TAPENTADOL 50MG TABLET;ORAL None (Tentative Approval) None No No
TAPENTADOL TAPENTADOL 75MG TABLET;ORAL None (Tentative Approval) None No No
TAPENTADOL TAPENTADOL 100MG 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
05/19/2015 ORIG-1 Tentative Approval STANDARD

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