Drugs@FDA: FDA Approved Drug Products

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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 None 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
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
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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