Cette traduction est en cours de préparation. En attendant, nous affichons temporairement la version originale en anglais.
Entreprise · 16/06/20141 min de lecture
Determination That LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 Milligrams/1 Milliliter, 10 Milliliter Total Fill Volume, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Traduction automatique locale · Langue originale de la source
Résumé
The Food and Drug Administration (FDA) has determined that LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 milligrams (mg)/1 milliliter (mL), 10 mL total fill volume, was not withdrawn from sale for reasons of safety or effectiveness.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-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, if all other legal and regulatory requirements are met.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →