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

7 rows where docket_id = "FDA-2019-E-5389" 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), comment_end_date (date), last_modified (date)

posted_year 4

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2019-E-5389-0007 FDA None FDA-2019-E-5389 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2022-08-29T04:00:00Z 2022 8 2022-08-29T04:00:00Z   2022-08-29T16:09:12Z   0 0 0900006485286663
FDA-2019-E-5389-0006 FDA None FDA-2019-E-5389 Determination of Regulatory Review Period for Purposes of Patent Extension; SUNOSI Notice Determinations 2021-11-19T05:00:00Z 2021 11 2021-11-19T05:00:00Z 2022-05-19T03:59:59Z 2021-11-19T16:16:11Z 2021-25297 0 0 0900006484e65e47
FDA-2019-E-5389-0005 FDA None FDA-2019-E-5389 Patent Term Extension Approval letter from FDA CDER Other Approval 2021-11-05T04:00:00Z 2021 11 2021-11-05T04:00:00Z   2021-11-05T15:31:14Z   0 0 0900006484e24dd2
FDA-2019-E-5389-0004 FDA None FDA-2019-E-5389 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2021-07-26T04:00:00Z 2021 7 2021-07-26T04:00:00Z   2021-07-26T16:57:25Z   0 0 0900006484c0f022
FDA-2019-E-5389-0003 FDA None FDA-2019-E-5389 Letter to U.S. Patent and Trademark Office from FDA CDER Other Letter(s) 2020-01-07T05:00:00Z 2020 1 2020-01-07T05:00:00Z   2020-01-07T19:43:23Z   0 0 0900006484279746
FDA-2019-E-5389-0001 FDA None FDA-2019-E-5389 Letter from U S Patent and Trademark Office Other Letter(s) 2019-11-14T05:00:00Z 2019 11 2019-11-14T05:00:00Z   2019-11-14T15:41:43Z   0 0 0900006484154e5f
FDA-2019-E-5389-0002 FDA None FDA-2019-E-5389 Patent Term Extension Application from Jazz Pharmaceuticals Inc Other Application 2019-11-14T05:00:00Z 2019 11 2019-11-14T05:00:00Z   2019-11-14T15:44:57Z   0 0 0900006484154e60

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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;