Reference Listed Drugs: FDA

A Reference Listed Drug (RLD) is a medicinal product, approved by the FDA, which can be referred to by a generic medicine manufacturer while filling an ANDA. An RLD is required to create bioequivalence of the product with that of an already approved product.

When a manufacturer of generic medicine is filling an Abbreviated New Drug Application (also known as ANDA), they must refer to the Reference Listed Drug designated by the Food and Drug Administration in the application portraying that the proposed generic medicine is identical in the context of active salt (active pharmaceutical ingredient), strength, dosage form, route of administration, and conditions of use, along with characteristics.

Reference Listed Drug is the standard to which all generic versions must be shown to be bioequivalent. The Food and Drug Administration hopes to eliminate the probable significant variations among generic medicines and their trade/brand name alternatives.

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