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# Guidance on ANDA References to Approved Drug Products
- URL: https://www.fdaweb.com/guidance-on-anda-references-to-approved-drug-products/
- Published: 2020-10-27T12:00:00.000Z
- Updated: 2026-09-14T16:34:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147960

FDA has published a guidance, *Referencing Approved Drug Products in ANDA Submissions*, providing information to potential applicants on how to identify a reference-listed drug (RLD), a reference standard, and the basis of submission in an ANDA. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/referencing-approved-drug-products-anda-submissions-guidance-industry?ref=fdaweb.com) says a variety of factors has led to confusion among stakeholders on what the terms RLD, reference standard, and basis of submission mean and now ANDA applicants should use them.

The factors, it says, include the discontinued marketing of many approved drug products and FDA’s past practice of identifying reference standards with the RLD symbol (“+”) in the printed version and with a “Yes” under the RLD column in the electronic version of the *Orange Book*.

“The purpose of this guidance is to address this confusion by explaining what these terms mean and by clarifying the differences among them,” FDA says. “This guidance provides recommendations on how applicants can accurately use these terms in an ANDA, how persons can request FDA designation of an RLD, and how persons can request FDA selection of a reference standard.”