Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022494
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM FLUORIDE F 18 SODIUM FLUORIDE F-18 10-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INTRAVENOUS Discontinued None No No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
01/26/2011 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Letter (PDF)
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022494s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022494Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022494Orig1s000SumR.pdf

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