{"database": "openregs", "table": "federal_register", "rows": [["2020-27082", "Allergan Pharmaceuticals International, Ltd.; Withdrawal of Approval of a New Drug Application for ASACOL (Mesalamine) Delayed-Release Tablets, 400 Milligrams", "Notice", "The Food and Drug Administration (FDA) is withdrawing the approval of the new drug application (NDA) for ASACOL (mesalamine) delayed-release tablets, 400 milligrams (mg), held by Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC, 2525 Dupont Dr., Irvine, CA 92612 (Allergan). Pursuant to FDA's request, Allergan agreed to withdrawal of this application and has waived its opportunity for a hearing.", "2020-12-10", 2020, 12, "https://www.federalregister.gov/documents/2020/12/10/2020-27082/allergan-pharmaceuticals-international-ltd-withdrawal-of-approval-of-a-new-drug-application-for", "https://www.govinfo.gov/content/pkg/FR-2020-12-10/pdf/2020-27082.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is withdrawing the approval of the new drug application (NDA) for ASACOL (mesalamine) delayed-release tablets, 400 milligrams (mg), held by Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC,...", 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": ["2020-27082"], "units": {}, "query_ms": 1.0978550417348742, "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"}