Abbreviated new drug application (ANDA)

A submission to the US Food and Drug Administration (FDA) for the review and potential approval of a generic drug product.

Once an ANDA has been approved, applicants can manufacture and market a generic product. Applications are “abbreviated” as they do not need to include the detailed evidence required for a new drug application (NDA). Rather, applicants must demonstrate their product is bioequivalent to a licensed drug (i.e. it has the same properties and acts in the same way as a licensed drug).

Abbreviated new drug application (ANDA) (U.S. Food and Drug Administration, 2019)

Factors that have an impact on abbreviated new drug application (ANDA) submissions (Therapeutic Innovation & Regulatory Science, 2020)

Common deficiencies with bioequivalence submissions in abbreviated new drug applications assessed by FDA (The AAPS Journal, 2012)