Zdrowie i gospodarka · 09/08/2018

Determination That PROLIXIN (Fluphenazine Hydrochloride) Tablets, 1 Milligram, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that PROLIXIN (fluphenazine hydrochloride) tablets, 1 milligram (mg), 2.5 mg, 5 mg, and 10 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for fluphenazine hydrochloride tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, if all other legal and regulatory requirements are met.