Zdrowie i gospodarka · 16.07.2019
Determination That MIOCHOL (Acetylcholine Chloride Intraocular Solution), 20 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that MIOCHOL (acetylcholine chloride intraocular solution), 20 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for acetylcholine chloride intraocular solution, 20 mg/vial, if all other legal and regulatory requirements are met.