Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203933
Company: UNIV TX MD ANDERSON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMMONIA N 13 AMMONIA N-13 30mCi-300mCi/8ML (3.75-37.5mCi/ML) INJECTABLE;INTRAVENOUS 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
06/27/2014 ORIG-1 Approval

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