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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022454
Company: GE HLTHCARE INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DATSCAN IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/30/2022 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022454Orig1s011lbl.pdf
11/30/2022 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022454Orig1s011lbl.pdf
11/01/2022 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022454s010lbl.pdf
03/25/2020 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022454s007lbl.pdf
09/11/2015 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022454Orig1s004lbl.pdf
01/14/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022454Orig1s000Lbl.pdf
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