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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/14/2011 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022454Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022454s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022454sOrig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022454sOrig1s000SumR.pdf
Supplements
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, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022454Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022454Orig1s011ltr.pdf
11/01/2022 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022454s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022454Orig1s010ltr.pdf
03/25/2020 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022454s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022454Orig1s007ltr.pdf
09/11/2015 SUPPL-4 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022454Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022454Orig1s004ltr.pdf
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

DATSCAN

SOLUTION;INTRAVENOUS; 5mCi/2.5ML (2mCi/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DATSCAN IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 022454 GE HLTHCARE INC
IOFLUPANE I-123 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION;INTRAVENOUS Prescription No AP 213792 CURIUM
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