Zdrowie i gospodarka · 06/08/2007

Determination That PHENERGAN (Promethazine Hydrochloride) Suppositories, 12.5 Milligrams and 25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA) has determined that PHENERGAN (promethazine hydrochloride (HCl)) suppositories, 12.5 milligrams (mg) and 25 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 promethazine HCl suppositories, 12.5 mg and 25 mg.