Glossary

Reference Listed Drug (RLD)

February 27, 2012

An FDA-approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the RLD in its ANDA. By designating a single RLD as the standard to which all generic versions must be shown to be bioequivalent, the FDA intends to avoid possible significant variations among generic drugs and brand counterparts.