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# Guide on Composition and Ingredient Statements
- URL: https://www.fdaweb.com/guide-on-composition-and-ingredient-statements/
- Published: 2024-04-29T12:00:00.000Z
- Updated: 2026-09-14T14:29:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156869

*Federal Register* notice: FDA is making available a draft guidance entitled “Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling.” The document is intended to assist NDA/ANDA applicants in submitting an accurate and complete composition statement in their applications and corresponding statement of ingredients in the labeling. It also describes best practices for writing both statements. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-04-29/pdf/2024-09156.pdf?ref=fdaweb.com).