Abbreviated New Drug Application (ANDA)
An abbreviated new drug application (ANDA) contains information submitted to the FDA for examination and possible approval of a generic drug product. Once approved, an application may produce and promote the generic drug product as a safe, effective, and less expensive alternative to the brand-name drug it references. It must prove that a proposed generic medicine is equivalent to an existing approved reference-listed drug (RLD) in terms of safety, efficacy, and quality.