ANDA

A generic drug product is one that is comparable to an innovator drug product (also known as the reference listed drug (RLD) product as identified in the FDA's list of Approved Drug Products with Therapeutic Equivalence Evaluations) in dosage form, strength, route of administration, quality, performance characteristics and intended use.

"ANDA" is the abbreviations for "Abbreviated New Drug Application."   It contains data which 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. Once approved an applicant may manufacture and market the generic drug product provided all issues related to patent protection and exclusivity associated with the RLD have been resolved.

Generic drug applications are termed "abbreviated" in that they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. These parameters were established upon the approval of the innovator drug product, which is the first version of the drug product approved by the FDA.