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Drugs@FDA: FDA-Approved Drugs

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New Drug Application:
Company:
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/16/2018 ORIG-1 Approval STANDARD

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