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# Guide on ANDA Cover Letter Attachments
- URL: https://www.fdaweb.com/guide-on-anda-cover-letter-attachments/
- Published: 2021-12-10T12:00:00.000Z
- Updated: 2026-09-14T17:25:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150749

FDA has published a draft guidance entitled [*Cover Letter Attachments for Controlled Correspondences and ANDA Submissions*](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMTEyMTAuNTAwOTk5MjEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L3JlZ3VsYXRvcnktaW5mb3JtYXRpb24vc2VhcmNoLWZkYS1ndWlkYW5jZS1kb2N1bWVudHMvY292ZXItbGV0dGVyLWF0dGFjaG1lbnRzLWNvbnRyb2xsZWQtY29ycmVzcG9uZGVuY2VzLWFuZC1hbmRhLXN1Ym1pc3Npb25zLWd1aWRhbmNlLWluZHVzdHJ5P3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSJ9.cwD0t79p%5FeVpJBMCv%5FQtLjhg9WpOXaHLmSa6JyFGZhc/s/1255720147/br/122791187775-l?ref=fdaweb.com). The document discusses optional attachments that can be used when preparing cover letters that accompany controlled correspondence to CDER’s Office of Generic Drugs, as well as original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA. Cover letters provide a submission overview and help FDA ensure that it is properly triaged and assigned to the appropriate assessors. The agency notes that the attachments do not replace the recommendations for the content of cover letters provided in other FDA guidances.