Determination That SYNDROS (Dronabinol) Solution, 5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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(FDA, Agency, or we) has determined that SYNDROS (dronabinol) solution, 5 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 SYNDROS (dronabinol) solution, 5 mg/ mL, if all other legal and regulatory requirements are met.
Abstract as published in the Federal Register.
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