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Abbreviated New Drug Application (ANDA): 213792
Company: CURIUM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IOFLUPANE I-123 IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) SOLUTION;INTRAVENOUS Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/30/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213792Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/12/2023 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

IOFLUPANE I-123

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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