{"database": "openregs", "table": "federal_register", "rows": [["2024-26915", "Determination That JESDUVROQ (daprodustat) Tablets, 1 Milligram, 2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness", "Notice", "The Food and Drug Administration (FDA, Agency, or we) has determined that JESDUVROQ (daprodustat) tablets, 1 milligram (mg), 2 mg, 4 mg, 6 mg, and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, if all other legal and regulatory requirements are met.", "2024-11-19", 2024, 11, "https://www.federalregister.gov/documents/2024/11/19/2024-26915/determination-that-jesduvroq-daprodustat-tablets-1-milligram-2-milligrams-4-milligrams-6-milligrams", "https://www.govinfo.gov/content/pkg/FR-2024-11-19/pdf/2024-26915.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA, Agency, or we) has determined that JESDUVROQ (daprodustat) tablets, 1 milligram (mg), 2 mg, 4 mg, 6 mg, and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["2024-26915"], "units": {}, "query_ms": 0.43109897524118423, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}