documents

Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

5 rows where docket_id = "FDA-2023-P-5687" sorted by posted_date descending

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Suggested facets: posted_date, posted_month, comment_start_date, posted_date (date), comment_start_date (date), last_modified (date)

posted_year 3

document_type 2

agency_id 1

id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2023-P-5687-0004 FDA None FDA-2023-P-5687 Determination That RIOMET (Metformin Hydrochloride) Oral Solution, 500 Milligrams/5 Milliliters Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2025-03-13T04:00:00Z 2025 3 2025-03-13T04:00:00Z   2025-03-13T12:52:25Z 2025-04020 0 0 09000064869e2d63
FDA-2023-P-5687-0005 FDA None FDA-2023-P-5687 Final Response Letter from FDA CDER to Bionpharma, Inc. Other Denial of Petition 2025-03-13T04:00:00Z 2025 3 2025-03-13T04:00:00Z   2025-03-13T19:27:27Z   0 0 09000064869e77d5
FDA-2023-P-5687-0003 FDA None FDA-2023-P-5687 Interim Response Letter from FDA CDER to Bionpharma, Inc. Other Response(s) 2024-06-20T04:00:00Z 2024 6 2024-06-20T04:00:00Z   2024-06-20T13:18:57Z   0 0 09000064865c0a3b
FDA-2023-P-5687-0001 FDA None FDA-2023-P-5687 Citizen Petition from Bionpharma, Inc. Other Citizen Petition 2023-12-27T05:00:00Z 2023 12 2023-12-27T05:00:00Z   2025-03-13T18:36:06Z   0 0 090000648635b114
FDA-2023-P-5687-0002 FDA None FDA-2023-P-5687 Acknowledgment Letter from FDA DMS to Bionpharma, Inc. Other Acknowledgement Letter/Receipt 2023-12-27T05:00:00Z 2023 12 2023-12-27T05:00:00Z   2023-12-27T12:31:11Z   0 0 090000648635b116

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;