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Imprese · 26/07/20021 min di lettura
Determination That Cyanocobalamin Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Riepilogo
The Food and Drug Administration (FDA) has determined that cyanocobalamin injection (Rubramin PC), 1 milligram (mg)/milliliter (mL) in a 10 mL vial (cyanocobalamin injection) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for cyanocobalamin injection.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →