Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200293
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARFORMOTEROL TARTRATE ARFORMOTEROL TARTRATE 15MCG(BASE)/2ML SOLUTION;INHALATION 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
08/05/2016 ORIG-1 Tentative Approval Not Applicable

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