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.
Glossary
Reference Listed Drug (RLD)
02.27.12
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