reference listed drug

A reference listed drug (RLD) is the original medication that has been approved by regulatory authorities, like the FDA, based on thorough testing for safety and effectiveness. When other companies make similar drugs—called generics—they must prove their product is equivalent to the RLD in dosage, safety, strength, and quality. The RLD serves as the benchmark for these generic versions, ensuring that patients receive medications that are just as safe and effective as the original. Essentially, it is the "standard" drug used as a reference point for developing and approving new, similar medications.