Determination That LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 Milligrams/1 Milliliter, 10 Milliliter Total Fill Volume, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

摘要

The Food and Drug Administration (FDA) has determined that LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 milligrams (mg)/1 milliliter (mL), 10 mL total fill volume, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, if all other legal and regulatory requirements are met.