Zdrowie i gospodarka · 23.05.2007
Determination That ESTROSTEP 21 (Ethinyl Estradiol and Norethindrone Acetate) Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that ESTROSTEP 21 (ethinyl estradiol and norethindrone acetate) tablets were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for the combination drug ethinyl estradiol and norethindrone acetate tablets, 0.02 milligram (mg)/1 mg, 0.03 mg/1 mg, and 0.035 mg/1 mg.