Abbreviated New Drug Application (ANDA)
Also known as: ANDA, Generic Drug Application
Verified from FDA Drugs@FDA Glossary on 06-02-2026An Abbreviated New Drug Application, or ANDA, is the regulatory pathway used by generic drug sponsors to obtain FDA approval. It is called abbreviated because the applicant generally relies on the safety and effectiveness findings of the original brand-name drug rather than repeating preclinical and clinical studies, demonstrating instead that the proposed generic is bioequivalent to the reference product. The FDA's own description of the ANDA pathway follows below.
MedivaScan summary. The authoritative source quote follows below.FDA Drugs@FDA Glossary definition
An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.