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Geschäft · 18.4.20121 Min. Lesezeit
Determination That FUNDUSCEIN-25 (fluorescein sodium injection), 25%, and AK-FLUOR (fluorescein sodium injection), 25%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA) has determined that FUNDUSCEIN-25 (fluorescein sodium injection), 25%, and AK-FLUOR (fluorescein sodium injection), 25%, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for fluorescein sodium injection, 25%, if all other legal and regulatory requirements are met.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →