reference listed drug
Also found in: Acronyms.
reference listed drugAn approved drug product to which new generic versions are compared to show bioequivalence. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application.
By designating a single reference-listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand-name counterpart.