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# Final ANDA Label Revision Guidance
- URL: https://www.fdaweb.com/final-anda-label-revision-guidance/
- Published: 2024-01-24T12:00:00.000Z
- Updated: 2026-09-14T14:21:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156197

FDA has published a guidance, *Revising ANDA Labeling Following Revision of the RLD Labeling*, to assist applicants and holders of ANDAs to update their labeling following revisions to the approved labeling of the reference-listed drug. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/revising-anda-labeling-following-revision-rld-labeling-guidance-industry?ref=fdaweb.com) provides recommendations for identifying reference-listed drug labeling updates and submitting ANDA amendments or supplements to update the generic drug labeling, FDA says. It finalizes a 1/27/2022 draft guidance, providing clear expectations for when updates to labeling are required, the process for updating labeling, and the types of submissions for labeling updates.