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Zdrowie i gospodarka · 26/04/2021

Determination That Sodium Chloride 14.6% Solution for Injection, 50 Milliequivalent/20 Milliliters, in Plastic Containers, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that Sodium Chloride 14.6% solution for injection, 50 milliequivalent (mEq)/20 milliliters (mL), in plastic containers, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for sodium chloride 14.6% solution for injection, 50 mEq/20 mL, in plastic containers, if all other legal and regulatory requirements are met.

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