Determination That Leucovorin Calcium, Oral Solution, Equivalent to 60 Milligrams Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that leucovorin calcium, oral solution, equivalent to (EQ) 60 milligrams (mg) base/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for leucovorin calcium, oral solution, EQ 60 mg, if all other legal and regulatory requirements are met.
Abstract as published in the Federal Register.
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