Zdrowie i gospodarka · 17/09/2004
Determination That ZOLOFT (Sertraline Hydrochloride) Tablets, 150 Milligrams and 200 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that ZOLOFT (sertraline hydrochloride (HCl)) Tablets, 150 milligrams (mg) and 200 mg (new drug application (NDA) 19-839), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for sertraline HCl tablets, 150 mg and 200 mg.