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# Guide on Submitting ANDA or 505(b)(2) NDA
- URL: https://www.fdaweb.com/guide-on-submitting-anda-or-505-b-2-nda/
- Published: 2019-05-10T12:00:00.000Z
- Updated: 2026-09-15T01:26:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144080

*Federal Register* notice: FDA has made available a guidance entitled “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” The document highlights criteria for submitting applications under the abbreviated approval pathways described in Section 505(j) and 505(b)(2), identifies considerations to help potential applicants determine whether an application would be more appropriately submitted under Section 505(j), and provides direction to potential applicants on requesting assistance from FDA in making this determination. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-05-10/pdf/2019-09662.pdf?ref=fdaweb.com).