Zdrowie i gospodarka · 26/04/2021

FDA Clears Sodium Chloride 14.6% Solution for Injection for Approval via Abbreviated New Drug Applications

The US Food and Drug Administration (FDA) has made a determination that the Sodium Chloride 14.6% solution for injection, 50 milliequivalent/20 milliliters, in plastic containers, was not withdrawn from sale due to safety or effectiveness concerns, paving the way for the approval of abbreviated new drug applications (ANDAs) for this product if all regulatory requirements are met.