Zdrowie i gospodarka · 04/10/2023

FDA Determines ULTRAM 50mg Tablets Were Not Withdrawn Due to Safety or Effectiveness Concerns

The Food and Drug Administration (FDA) has determined that the 50mg tramadol hydrochloride tablet, marketed as ULTRAM, was not withdrawn from sale due to safety or effectiveness concerns. This decision means the FDA will not initiate withdrawal procedures for abbreviated new drug applications (ANDAs) referencing this product.