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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215840
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215877
https://www.federalregister.gov/documents/2018/12/28/2018-28221/determination-of-regulatory-review-period-for-purposes-of-patent-extension-parsabiv