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Reference Listed Drug (RLD)

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By: DAVID SAVASTANO

Contributing Editor, Coatings World and Ink World, Coatings World and Ink World Magazine

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.

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