Determination That ARISTOSPAN (Triamcinolone Hexacetonide) Injectable Suspension, 20 Milligrams/Milliliter and 5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 ARISTOSPAN (triamcinolone hexacetonide) injectable suspension, 20 milligrams (mg)/milliliter (mL) and 5 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness.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 triamcinolone hexacetonide injectable suspension, 20 mg/mL and 5 mg/mL, if all other legal and regulatory requirements are met.
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