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# Draft ANDA Amendment Submission Guidance
- URL: https://www.fdaweb.com/draft-anda-amendment-submission-guidance/
- Published: 2019-01-16T12:00:00.000Z
- Updated: 2026-09-15T00:54:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143164

FDA has issued a draft guidance, *ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs*, to assist applicants in preparing and submitting amendments to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/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM629489.pdf?ref=fdaweb.com) says it provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission 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 includes an Introduction, Background, Amendments to Tentatively Approved ANDAs, Submission of and Review Goals for Requests for Final Approval, Post-TA Changes that May Impact Final Approval, and Content of Requests for Final Approval.