Determination That Ibuprofen 200-Milligram Capsule Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

摘要

The Food and Drug Administration (FDA) has determined that ibuprofen (Midol ) 200-milligram (mg) capsule was not withdrawn from sale for reasons of safety or effectiveness.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 ibuprofen 200-mg capsule.