Zdrowie i gospodarka · 10.04.2000
Determination That Carbinoxamine Maleate 4 Milligrams per 5 Cubic Centimeters Elixir Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that carbinoxamine maleate (Clistin) 4 milligrams (mg) per 5 cubic centimeters (cc) elixir was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDA's) for carbinoxamine maleate 4 mg per 5 cc elixir.