> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft Guide on Referencing Approved Products in ANDAs
- URL: https://www.fdaweb.com/draft-guide-on-referencing-approved-products-in-andas/
- Published: 2017-01-13T12:00:00.000Z
- Updated: 2026-09-14T22:00:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137725

FDA has posted a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM536962.pdf?ref=fdaweb.com) on “Referencing Approved Drug Products in ANDA Submissions” that provides information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in ANDA submissions. A reference standard selected by FDA is the specific drug product that the ANDA applicant must use in conducting any in vivo bioequivalence testing required to support approval of its ANDA,” the document says. The reference standard is typically the RLD. However, in some instances the RLD is no longer marketed, and the reference standard is a drug product other than the RLD.