BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 24/06/2020

Determination That DEXTROSE IN PLASTIC CONTAINER (Dextrose) Injectable, 30 Grams/100 Milliliters, 40 Grams/100 Milliliters, 60 Grams/100 Milliliters, and 70 Grams/100 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that DEXTROSE IN PLASTIC CONTAINER (dextrose) injectable, 30 grams (g)/100 milliliters (mL), 40 g/100 mL, 60 g/100 mL, and 70 g/100 mL, were not withdrawn from sale for reasons of safety or effectiveness.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 injectable, 30 g/100 mL, 40 g/100 mL, 60 g/100 mL, and 70 g/100 mL, if all other legal and regulatory requirements are met.

Source: Federal Register — Food and Drug AdministrationOpen original release →