Determination That OXYTOCIN in 5% Dextrose Injection Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that OXYTOCIN 5 United States Pharmacopeia (USP) Units in Dextrose 5% (oxytocin), injectable, injection, 5 USP Units in 500 milliliters (mL), (1 USP Unit/100 mL); OXYTOCIN 10 USP Units in Dextrose 5% (oxytocin), injectable, injection, 10 USP Units in 500 mL, (2 USP Units/100 mL); OXYTOCIN 10 USP Units in Dextrose 5% (oxytocin), injectable, injection, 10 USP Units in 1000 mL, (1 USP Unit/100 mL); and OXYTOCIN 20 USP Units in Dextrose 5% (oxytocin), injectable, injection, 20 USP Units in 1000 mL, (2 USP Units/100 mL), (hereinafter ``these oxytocin drug products'') were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve an abbreviated new drug application (ANDA) for these oxytocin drug products, if all other legal and regulatory requirements are met.