Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078613
Company: BARR LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARIPIPRAZOLE ARIPIPRAZOLE 2MG TABLET; ORAL None (Tentative Approval) None No No
ARIPIPRAZOLE ARIPIPRAZOLE 5MG TABLET; ORAL None (Tentative Approval) None No No
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET; ORAL None (Tentative Approval) None No No
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET; ORAL None (Tentative Approval) None No No
ARIPIPRAZOLE ARIPIPRAZOLE 20MG TABLET; ORAL None (Tentative Approval) None No No
ARIPIPRAZOLE ARIPIPRAZOLE 30MG 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
10/12/2012 ORIG-1 Tentative Approval

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