Zdrowie i gospodarka · 17/02/2021
Determination That NYMALIZE (nimodipine), Oral Solution, 3 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, the Agency, or we) has determined that NYMALIZE (nimodipine), oral solution, 3 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 nimodipine, oral solution, 3 mg/mL, if all other legal and regulatory requirements are met.