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# Draft Guide on ANDA Sameness Evaluations
- URL: https://www.fdaweb.com/draft-guide-on-anda-sameness-evaluations/
- Published: 2022-11-09T12:00:00.000Z
- Updated: 2026-09-14T18:05:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153161

*Federal Register* notice: FDA is making available a draft guidance entitled “Sameness Evaluations in an ANDA — Active Ingredients.” The document provides recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-11-09/pdf/2022-24432.pdf?ref=fdaweb.com).