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-2021-P-0923" 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 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2021-P-0923-0005 FDA None FDA-2021-P-0923 Agency Response Letter from FDA CDER to Gland Pharma Limited Other Agency Response 2021-12-22T05:00:00Z 2021 12 2021-12-22T05:00:00Z   2021-12-22T20:33:10Z   0 0 0900006484ee7299
FDA-2021-P-0923-0004 FDA None FDA-2021-P-0923 Determination That ANTIZOL (Fomepizole) Injection, 1.5 Grams/1.5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2021-12-22T05:00:00Z 2021 12 2021-12-22T05:00:00Z   2021-12-22T13:22:01Z 2021-27699 0 0 0900006484ee09d0
FDA-2021-P-0923-0003 FDA None FDA-2021-P-0923 Attachment - I current orange book status re Citizen Petition from Gland Pharma Limited Supporting & Related Material Background Material 2021-08-20T04:00:00Z 2021 8     2021-08-20T12:57:54Z   0 0 0900006484c8d400
FDA-2021-P-0923-0002 FDA None FDA-2021-P-0923 Acknowledgment Letter from FDA DMS to Gland Pharma Limited Other Acknowledgement Letter/Receipt 2021-08-20T04:00:00Z 2021 8 2021-08-20T04:00:00Z   2021-08-20T12:57:49Z   0 0 0900006484c8cb24
FDA-2021-P-0923-0001 FDA None FDA-2021-P-0923 Citizen Petition from Gland Pharma Limited Other Citizen Petition 2021-08-20T04:00:00Z 2021 8 2021-08-20T04:00:00Z   2021-12-22T20:33:27Z   0 0 0900006484c8d3fe

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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    withdrawn INTEGER,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;