Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017243
Company: CURIUM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULTRA-TECHNEKOW FM TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 0.25-3 CI/GENERATOR SOLUTION;INTRAVENOUS Discontinued None No No
ULTRA-TECHNEKOW FM TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 1-19 CI/GENERATOR SOLUTION;INTRAVENOUS Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/04/2015 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017243Orig1s046lbl.pdf
02/18/2014 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017243s043lbl.pdf
12/20/2013 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017243Orig1s044lbl.pdf
10/15/2004 SUPPL-25 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17243s025lbl.pdf

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