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# Comments Extended for Guide on Submitting ANDA/505(b)(2)
- URL: https://www.fdaweb.com/comments-extended-for-guide-on-submitting-anda-505-b-2/
- Published: 2018-01-12T12:00:00.000Z
- Updated: 2026-09-14T23:13:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140488

*Federal Register* notice: FDA has reopened the comment period until 2/12 on a draft guidance on “Determining Whether to Submit an ANDA or a 505(b)(2) Application.”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-2018-01-12/pdf/2018-00405.pdf?ref=fdaweb.com).