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# Guidance on Refuse to Receive ANDAs for Lack of Impurity Info
- URL: https://www.fdaweb.com/guidance-on-refuse-to-receive-andas-for-lack-of-impurity-info/
- Published: 2016-08-25T12:00:00.000Z
- Updated: 2026-09-14T21:26:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136618

*Federal Register* Notice: FDA is making available a guidance for industry entitled *Abbreviated New Drug Application Submissions — Refuse to Receive for Lack of Justification of Impurity Limits*. It is intended to assist applicants preparing to submit to FDA ANDAs and prior approval supplements for which the applicant is seeking approval of a new strength of the drug product. The guidance highlights deficiencies about impurity information that may cause FDA to refuse to receive an ANDA. To download this guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM414598.pdf?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-25/pdf/2016-20399.pdf?ref=fdaweb.com)