Бизнес · 26.07.20021 мин чтения
Determination That Cyanocobalamin Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Локальный автоматический перевод · Язык оригинального источника
Краткое содержание
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injection (Rubramin PC), 1 milligram (mg)/milliliter (mL) in a 10 mL vial (cyanocobalamin injection) was not withdrawn from sale for reasons of safety or effectiveness.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.