Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205687
Company: ESSENTIAL ISOTOPES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMMONIA N 13 AMMONIA N-13 3.75-260mCi/ML INJECTABLE;INTRAVENOUS Prescription 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
12/17/2015 ORIG-1 Approval STANDARD

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