Imprese · 10/03/20141 min di lettura
Determination That ZEFAZONE (Cefmetazole Sodium) Injection, Equivalent to 1 Gram Base/Vial and Equivalent to 2 Gram Base/Vial, and ZEFAZONE (Cefmetazole Sodium) Intravenous Solution, Equivalent to 20 Milligrams Base/Milliliter and Equivalent to 40 Milligrams Base/Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 ZEFAZONE (cefmetazole sodium) Injection, equivalent to (EQ) 1 gram (g) base/vial and EQ 2 g base/vial, and ZEFAZONE (cefmetazole sodium) Intravenous (IV) Solution, EQ 20 milligrams (mg) base/milliliter (mL) and EQ 40 mg base/mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ZEFAZONE (cefmetazole sodium) Injection, EQ 1 g base/vial and EQ 2 g base/vial, and ZEFAZONE (cefmetazole sodium) IV Solution, EQ 20 mg base/mL and 40 mg base/mL, if all other legal and regulatory requirements are met.