Zdrowie i gospodarka · 25.03.2010
Determination That DIDREX (Benzphetamine Hydrochloride) Tablets, 25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that DIDREX (benzphetamine hydrochloride (HCl)) Tablets, 25 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for benzphetamine HCl 25 mg tablets, if all other legal and regulatory requirements are met.