Zdrowie i gospodarka · 29.10.1997
Determination That Pseudoephedrine Hydrochloride 120-Milligram Extended-Release Capsules Over-the-Counter Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that pseudoephedrine hydrochloride (Sudafed 12-Hour Capsules) 120-milligram (mg) extended-release capsules over-the-counter (OTC) were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDA's) for pseudoephedrine hydrochloride 120-mg extended-release capsules.