RLD
Medical abbreviation · Pharmacy
| Stands for | Reference listed drug |
|---|---|
| Categories | Medical |
RLD stands for Reference listed drug, a pharmacy abbreviation.
Approved drug product that a generic applicant must compare its product to when seeking approval through an ANDA. The RLD is usually the original brand-name product listed in the FDA's Orange Book.
Example: The ANDA's bioequivalence study used Lipitor as the RLD.
Usage notes
If the RLD is withdrawn for reasons other than safety, the FDA may designate a "reference standard", often a generic, for future bioequivalence testing. Generic companies sometimes struggle to buy RLD samples when brands restrict distribution, a problem addressed by the 2019 CREATES Act.
Related abbreviations
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This entry is for general education and is not medical advice. Abbreviation use varies between institutions; always confirm in context.