Determination That METHERGINE (Methylergonovine Maleate) Injection, 0.2 Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

摘要

The Food and Drug Administration (FDA or Agency) has determined that METHERGINE (methylergonovine maleate) injection, 0.2 milligram (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 methylergonovine maleate injection, 0.2 mg/mL, if all other legal and regulatory requirements are met.