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Product safetyFDAUnited StatesImports

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(Autoinjector) (Pralidoxime Chloride) Solution, 600 Milligrams/2 Milliliters (300 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

6 October 2026

In plain English

FDA determined that Pralidoxime Chloride (Autoinjector) solution, 600 mg/2 mL (300 mg/mL), was not withdrawn for safety or effectiveness reasons, allowing approval of ANDAs for this drug if other requirements are met.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
6 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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CHLORIDE (AUTOINJECTOR) (pralidoxime chloride) solution, 600 milligrams (mg)/2 milliliters (mL) (300 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness.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.

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