Determination That Cupric Sulfate Injection, Equivalent to 0.4 Milligram Copper/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) has determined that Cupric Sulfate Injection, equivalent to (EQ) 0.4 milligram (mg) copper/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 Cupric Sulfate Injection, EQ 0.4 mg copper/mL, if all other legal and regulatory requirements are met.
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