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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020570
Company: LANTHEUS MEDICAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUADRAMET SAMARIUM SM-153 LEXIDRONAM PENTASODIUM 50mCi/ML INJECTABLE;INJECTION Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/21/2017 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020570s008lbl.pdf
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