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# Draft Guide on ANDA Amendments for Final Approval
- URL: https://www.fdaweb.com/draft-guide-on-anda-amendments-for-final-approval/
- Published: 2019-02-04T12:00:00.000Z
- Updated: 2026-09-15T01:00:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143286

*Federal Register* notice: FDA has issued a draft guidance, *ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs*. 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. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-02-01/pdf/2019-00680.pdf?ref=fdaweb.com).