ABSTRACT
Approval of an Abbreviated New Drug Application (ANDA) is only the beginning of a generic drug product’s history. Frequently, changes are made to the chemistry and manufacturing controls of an ANDA following approval and continue throughout the life of the product. A pharmaceutical manufacturer may make changes in the drug formulation, batch size, process, equipment, or manufacturing site, which a¡ects the identity, strength, quality, purity, and potency of the ¢nished product. Therefore, any change must be fully evaluated prior to implementation to determine its impact on the ¢nished product as they may relate to safety or e¡ectiveness.
