Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208049
Company: ACCORD HLTHCARE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET;ORAL None (Tentative Approval) None No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET;ORAL None (Tentative Approval) None No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET;ORAL None (Tentative Approval) None No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET;ORAL None (Tentative Approval) None No No
LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG 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
10/12/2016 ORIG-1 Tentative Approval STANDARD

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