Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209167
Company: ACCORD HLTHCARE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TADALAFIL TADALAFIL UNKNOWN UNKNOWN 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
08/16/2018 ORIG-1 Tentative Approval STANDARD

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