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ANDA

Meaning

An Abbreviated New Drug Application, or ANDA, is a regulatory submission to the United States Food and Drug Administration required for the approval of a generic drug product. This application certifies that the proposed generic medication is bioequivalent to and therapeutically interchangeable with a previously approved, brand-name reference listed drug. The process ensures that the generic version delivers the same quantity of active pharmaceutical ingredient into the bloodstream over the same period as the innovator drug, confirming equivalent performance characteristics.