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Regulations.gov document: Reference 18 - FDA, TAVNEOS (avacopan). ‘‘Multi-Discipline Review.’’ NDA 214487, Oct. 12, 2018, available at https://www.access data.fda.gov/drugsatfda_docs/nda/2021/214487Orig1s000MultidisciplineR.pdf (accessed Apr. 24. 2016). — retained record — High Signal