Determination PRALIDOXIME CHLORIDE (Autoinjector) (Pralidoxime Chloride) Solution, 600 Milligrams/2 Milliliters (300 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA, Agency, or we) has determined that PRALIDOXIME CHLORIDE (AUTOINJECTOR) (pralidoxime chloride) solution, 600 milligrams (mg)/2 milliliters (mL) (300 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness.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 pralidoxime chloride solution, 600 mg/2 mL (300 mg/mL), if all other legal and regulatory requirements are met.

From Federal Register — all agencies (federalregister.gov). First seen Oct 10, 2026.

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