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Entreprise · 20/08/20191 min de lecture

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That Dextrose, 20 Grams/100 Milliliters, and Dextrose, 50 Grams/100 Milliliters, in Plastic Containers, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Résumé

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determined that Dextrose, 20 grams (g)/100 milliliters (mL), and Dextrose, 50 g/100 mL, in plastic containers, were not withdrawn from sale for reasons of safety or effectiveness.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.

Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →

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