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Geschäft · 20.8.20191 Min. Lesezeit
Determination That Dextrose, 20 Grams/100 Milliliters, and Dextrose, 50 Grams/100 Milliliters, in Plastic Containers, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA or Agency) has determined that Dextrose, 20 grams (g)/100 milliliters (mL), and Dextrose, 50 g/100 mL, in plastic containers, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic containers, if all other legal and regulatory requirements are met.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →