Determination That Cyanocobalamin Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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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injection (Rubramin PC), 1 milligram (mg)/milliliter (mL) in a 10 mL vial (cyanocobalamin injection) was not withdrawn from sale for reasons of safety or effectiveness.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.