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# Guide on ANDAs for Synthetic Peptide Products
- URL: https://www.fdaweb.com/guide-on-andas-for-synthetic-peptide-products/
- Published: 2021-05-20T12:00:00.000Z
- Updated: 2026-09-14T16:59:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149364

*Federal Register* notice: FDA has made available a final guidance entitled *ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin*. The document is intended to help potential applicants in determining when an application for a synthetic peptide drug product that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid origin should be submitted as an ANDA rather than an NDA. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-05-20/pdf/2021-10603.pdf?ref=fdaweb.com).