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# Draft Guide on Whether to Submit ANDA or 505(b)(2) Application
- URL: https://www.fdaweb.com/draft-guide-on-whether-to-submit-anda-or-505-b-2-application/
- Published: 2017-10-13T12:00:00.000Z
- Updated: 2026-09-14T22:56:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139861

*Federal Register* notice: FDA has made available a draft guidance on “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” The document is intended to assist applicants in determining which one of the abbreviated approval pathways is appropriate for submitting a marketing application to the agency. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-13/pdf/2017-22196.pdf?ref=fdaweb.com).