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

6 rows where docket_id = "FDA-2021-P-1354" sorted by posted_date descending

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

posted_year 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2021-P-1354-0006 FDA None FDA-2021-P-1354 Response Letter from FDA CDER to Cardinal Health Regulatory Sciences Other Response(s) 2022-04-13T04:00:00Z 2022 4 2022-04-13T04:00:00Z   2022-04-13T14:35:27Z   0 0 0900006485015b15
FDA-2021-P-1354-0005 FDA None FDA-2021-P-1354 Determination That TOTECT (Dexrazoxane Hydrochloride) for Injection, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2022-04-13T04:00:00Z 2022 4 2022-04-13T04:00:00Z   2022-04-13T13:10:40Z 2022-07942 0 0 090000648501558d
FDA-2021-P-1354-0001 FDA None FDA-2021-P-1354 Citizen Petition from Cardinal Health Regulatory Sciences Other Citizen Petition 2021-12-27T05:00:00Z 2021 12 2021-12-27T05:00:00Z   2022-04-13T14:35:43Z   0 0 0900006484efd9a0
FDA-2021-P-1354-0004 FDA None FDA-2021-P-1354 Orange Book August 2021 Changes List re Citizen Petition from Cardinal Health Regulatory Sciences Supporting & Related Material Background Material 2021-12-27T05:00:00Z 2021 12     2021-12-27T18:24:41Z   0 0 0900006484efdb6f
FDA-2021-P-1354-0002 FDA None FDA-2021-P-1354 Acknowledgment Letter from FDA DMS to Cardinal Health Regulatory Sciences Other Acknowledgement Letter/Receipt 2021-12-27T05:00:00Z 2021 12 2021-12-27T05:00:00Z   2021-12-27T18:24:22Z   0 0 0900006484efdb74
FDA-2021-P-1354-0003 FDA None FDA-2021-P-1354 Attachment 1 Orange Book - Therapeutic Equiv to TOTECT re Citizen Petition from Cardinal Health Regulatory Sciences Supporting & Related Material Background Material 2021-12-27T05:00:00Z 2021 12     2021-12-27T18:24:34Z   0 0 0900006484efdb6e

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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;