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Geschäft · 18.3.20261 Min. Lesezeit
Determination That METHERGINE (Methylergonovine Maleate) Injection, 0.2 Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
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has determined that METHERGINE (methylergonovine maleate) injection, 0.2 milligram (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →