The Food and Drug Administration (FDA or Agency) has determined that SODIUM IODIDE I 123 (sodium iodide I-123), oral solution, 2 millicuries (mCi)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for sodium iodide I 123, oral solution, 2 mCi/mL, if all other legal and regulatory requirements are met.
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Determination That SODIUM IODIDE I 123 (Sodium Iodide I-123), Oral Solution, 2 Millicuries/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that SODIUM IODIDE I 123 (sodium iodide I-123), oral solution, 2 millicuries (mCi)/milliliter (mL), was not withd...
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83 FR 22079
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“Determination That SODIUM IODIDE I 123 (Sodium Iodide I-123), Oral Solution, 2 Millicuries/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” thefederalregister.org (May 11, 2018), https://thefederalregister.org/documents/2018-10099/determination-that-sodium-iodide-i-123-sodium-iodide-i-123-oral-solution-2-millicuries-milliliter-was-not-withdrawn-from.