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# ANDA Final Approval Guidance
- URL: https://www.fdaweb.com/anda-final-approval-guidance/
- Published: 2024-01-24T12:00:00.000Z
- Updated: 2026-09-14T14:21:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156203

FDA has published a guidance, *ANDA Submissions — Amendments and Requests for Final Approval to Tentatively Approved ANDAs*, to assist applicants in preparing and submitting amendments to tentatively approved ANDAs, including requests for final approval. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/anda-submissions-amendments-and-requests-final-approval-tentatively-approved-andas?utm%5Fmedium=email&utm%5Fsource=govdelivery) provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submissions in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections.

The guidance replaces a 9/2020 final guidance on the same subject to incorporate the performance goals in the GDUFA 3 agreement. It also describes how FDA will handle requests for final approval and amendments to tentatively approved ANDAs subject to the performance goals under GDUFA 3\. FDA says it also contains clarifying revisions to a section concerning patent certifications and exclusivities and their effect on the timing of ANDA approval.