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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210156
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APIXABAN APIXABAN 2.5MG TABLET;ORAL None (Tentative Approval) None No No
APIXABAN APIXABAN 5MG 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
01/04/2019 ORIG-1 Tentative Approval STANDARD

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