Zdrowie i gospodarka · 16/11/2004
Determination That DYCLONE (Dyclonine Hydrochloride) 0.5% and 1.0% Topical Solutions Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that DYCLONE (dyclonine hydrochloride (HCl)) 0.5% and 1.0% Topical Solutions were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for DYCLONE HCl 0.5 and 1.0% Topical Solutions.