What Does ANDA Stand For?

ANDA stands for Abbreviated New Drug Application

ANDA, or Abbreviated New Drug Application, is a submission made to the U.S. Food and Drug Administration (FDA) for the approval of a generic drug. This application demonstrates that the proposed generic product is bioequivalent to an already approved brand-name drug, allowing for a streamlined review process. By providing a pathway for the introduction of lower-cost alternatives to branded medications, ANDAs play a crucial role in enhancing access to essential treatments while maintaining safety and efficacy standards.

Other Meanings for ANDA