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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022119
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 Prescription AP Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/05/2011 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022119s001lbl.pdf
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