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# Revised Guide on ANDA Submissions
- URL: https://www.fdaweb.com/revised-guide-on-anda-submissions/
- Published: 2019-06-14T12:00:00.000Z
- Updated: 2026-09-15T01:32:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144340

FDA has revised its [guidance](https://www.fda.gov/media/127905/download?ref=fdaweb.com) on “ANDA Submissions — Content and Format.” The document is intended to assist applicants in preparing ANDAs and it details the information that should be provided in each section of the common technical document (CTD) format. The CTD collects quality, safety, and efficacy information into a common format that has been adopted by international regulatory authorities. ANDAs and submissions to ANDAs (amendments, supplements, and reports) must be submitted to FDA electronically in the eCTD format.