Zdrowie i gospodarka · 12/04/2011

Determination That KEFLEX (Cephalexin) Capsule, Equivalent to 333 Milligrams Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA) has determined that KEFLEX (cephalexin) capsule, equivalent to (EQ) 333 milligrams (mg) base, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for cephalexin capsule, EQ 333 mg base, if all other legal and regulatory requirements are met.