Determination That Cimetidine 100 mg Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

摘要

The Food and Drug Administration (FDA) has determined that cimetidine 100 milligram (mg) tablets were not withdrawn from sale for reasons of safety or effectiveness.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 drugs that refer to cimetidine 100 mg tablets.