İş dünyası · 30.12.20021 dk okuma
Determination That Diazepam Autoinjector Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Yerel otomatik çeviri · Kaynağın orijinal dili
Özet
The Food and Drug Administration (FDA) has determined that Diazepam Autoinjector (diazepam for injection) 5 milligrams per milliliter (mg/mL) was not withdrawn from sale for reasons of safety or effectiveness.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 diazepam for injection 5 mg/mL.