Determination That Four Heparin Sodium In Sodium Chloride In Plastic Container (Heparin Sodium) Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

摘要

The Food and Drug Administration (FDA or Agency) has determined that HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 milliliters (mL); HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL; HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 10,000 units/100 mL; and HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL under new drug application (NDA) 019802 were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these products if all other legal and regulatory requirements are met.