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Zdrowie i gospodarka · 07/06/2021

Determination That QUELICIN PRESERVATIVE FREE (Succinylcholine Chloride) Injection, 20 Milligrams/Milliliter, 50 Milligrams/Milliliter, and 100 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 milligrams (mg)/milliliter (mL), 50 mg/mL, and 100 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness.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 QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, if all other legal and regulatory requirements are met.

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