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# Guide on ANDA Prior Approval Supplements
- URL: https://www.fdaweb.com/guide-on-anda-prior-approval-supplements-2/
- Published: 2016-10-17T12:00:00.000Z
- Updated: 2026-09-14T21:39:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137095

*Federal Register* Notice: FDA has made available a guidance on “ANDA Submissions — Prior Approval Supplements Under GDUFA.” The document is intended to assist applicants preparing to submit prior approval supplements and amendments to prior supplements. It also describes FDA’s performance metric goals for such supplements. To view this guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM404441.pdf?ref=fdaweb.com). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-10-17/pdf/2016-25037.pdf?ref=fdaweb.com).