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Imprese · 05/08/20131 min di lettura
Determination That CYTOXAN (Cyclophosphamide) for Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
The Food and Drug Administration (FDA) has determined that CYTOXAN (cyclophosphamide) for Injection (lyophilized formulations), 100 milligrams (mg)/vial, 200 mg/vial, 500 mg/vial, 1 gram (g)/vial, and 2 g/vial, and CYTOXAN (cyclophosphamide) for Injection (non- lyophilized formulations), 100 mg/vial and 200 mg/vial, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for these products, if all other legal and regulatory requirements are met.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →