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Abbreviated New Drug Application



An Abbreviated New Drug Application (ANDA) is submitted to the FDA when seeking review and approval for a generic drug product. The application is submitted to the FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. If approved, the generic drug may be manufactured and sold in the U.S. market.

Generic drug applications are not typically required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. An applicant submitting an ANDA must scientifically demonstrate that its product is bioequivalent to the previously approved innovator or brand name drug.

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