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Zdrowie i gospodarka · 25/05/2021

Determination That MANGANESE SULFATE, Injectable, Equivalent 0.1 Milligram Manganese/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that MANGANESE SULFATE, injectable, equivalent (Eq) 0.1 milligram (mg) manganese/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for MANGANESE SULFATE, injectable, Eq 0.1 mg manganese/mL, if all other legal and regulatory requirements are met.

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