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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204667
Company: SOFIE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMMONIA N 13 AMMONIA N-13 18.8mCi-188mCi/5ML (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
04/22/2015 ORIG-1 Approval STANDARD

Label is not available on this site.
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