{"database": "openregs", "table": "federal_register", "rows": [["2021-16046", "Product-Specific Guidance for Olodaterol Hydrochloride; Tiotropium Bromide; Draft Guidance for Industry; Availability", "Notice", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide.\" The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for olodaterol hydrochloride; tiotropium bromide inhalation spray.", "2021-07-28", 2021, 7, "https://www.federalregister.gov/documents/2021/07/28/2021-16046/product-specific-guidance-for-olodaterol-hydrochloride-tiotropium-bromide-draft-guidance-for", "https://www.govinfo.gov/content/pkg/FR-2021-07-28/pdf/2021-16046.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide.\" The draft guidance, when finalized, will provide...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url",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": ["2021-16046"], "units": {}, "query_ms": 0.42934692464768887, "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"}