Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017042
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUORINE F-18 SODIUM FLUORIDE F-18 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INTRAVENOUS Discontinued None Yes No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
02/24/1972 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

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