reference listed drug
- Guideline or reference source
- FDA www.fda.gov
- Definition
- An 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 Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
- Abbreviation for
- RLD
- Related Term
- abbreviated new drug application
- bioequivalence
- generic medicinal product
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