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Abbreviated New Drug Application (ANDA)
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An Abbreviated New Drug Application (ANDA) includes information submitted to the Federal Drug Administration (FDA) Center for Drug Evaluation and Research, Office of Generic Drugs, for review and approval of a generic drug product. If approved, the generic drug may be manufactured and marketed in the United States. Generic drug applications are termed "abbreviated" because the applications are not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.  Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). 



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