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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207322
Company: GLAND
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POLYMYXIN B SULFATE POLYMYXIN B SULFATE EQ 500,000 UNITS BASE/VIAL INJECTABLE;INJECTION Discontinued 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
04/14/2016 ORIG-1 Approval STANDARD

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