ANDA is an application for a U.S. generic drug approval for an existing approved or licensed drug. An ANDA contains data for review and possible approval of a generic drug product. They are not usually required to contain preclinical and clinical trial data to establish the efficacy and safety of the drug. However, generic drug applicants must scientifically demonstrate that their product is bioequivalent to the innovator/brand drug through some methods, such as measuring the time it takes for the generic drug to reach the bloodstream of healthy volunteers. https://www.proregulations.com/u-s-abbreviated-new-drug-application-anda.html