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

10 rows where docket_id = "FDA-2016-P-4388" 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 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-P-4388-0013 FDA None FDA-2016-P-4388 Response Letter from FDA CDER to Dr. S. Varghese Other Agency Response 2020-12-11T05:00:00Z 2020 12 2020-12-11T05:00:00Z   2020-12-11T15:24:39Z   0 0 090000648499895d
FDA-2016-P-4388-0010 FDA None FDA-2016-P-4388 CHPA response to Citizen Petition Loperamide OTC to Rx 090517 FINAL Other Reply Comments 2017-09-11T04:00:00Z 2017 9 2017-09-11T04:00:00Z   2017-09-11T14:01:33Z   0 0 0900006482b249b2
FDA-2016-P-4388-0009 FDA None FDA-2016-P-4388 Interim Response Letter from FDA CDER to Dr. S. Varghese Other Letter(s) 2017-06-19T04:00:00Z 2017 6 2017-06-19T04:00:00Z   2017-06-19T19:39:39Z   0 0 09000064826f191b
FDA-2016-P-4388-0004 FDA None FDA-2016-P-4388 Citizen Petition Reference List Re. Citizen Petition from S. Varghese Supporting & Related Material Background Material 2016-12-29T05:00:00Z 2016 12     2016-12-29T17:34:01Z   0 0 090000648243acf8
FDA-2016-P-4388-0003 FDA None FDA-2016-P-4388 Baker, a Pharmacological Review 2007 Re. Citizen Petition from S. Varghese Supporting & Related Material Background Material 2016-12-29T05:00:00Z 2016 12     2016-12-29T17:33:57Z   0 0 090000648243acf7
FDA-2016-P-4388-0005 FDA None FDA-2016-P-4388 Loperamide Abuse and Dependence 2015 Re. Citizen Petition from S. Varghese Supporting & Related Material Background Material 2016-12-29T05:00:00Z 2016 12     2016-12-29T17:34:05Z   0 0 090000648243acf9
FDA-2016-P-4388-0006 FDA None FDA-2016-P-4388 Loperamide Induced TDP, Re. Citizen Petition from S. Varghese Supporting & Related Material Background Material 2016-12-29T05:00:00Z 2016 12     2016-12-29T17:34:08Z   0 0 090000648243acfa
FDA-2016-P-4388-0002 FDA None FDA-2016-P-4388 Acknowledgment Letter from FDA DDM to Dr. S. Varghese Other Acknowledgement Letter/Receipt 2016-12-29T05:00:00Z 2016 12 2016-12-29T05:00:00Z   2016-12-29T17:33:53Z   0 0 090000648240c140
FDA-2016-P-4388-0001 FDA None FDA-2016-P-4388 Citizen Petition from Dr. S. Varghese Other Citizen Petition 2016-12-29T05:00:00Z 2016 12 2016-12-29T05:00:00Z 2017-06-27T03:59:59Z 2020-12-11T15:25:03Z   0 0 090000648240c13d
FDA-2016-P-4388-0007 FDA None FDA-2016-P-4388 Poor man's Methadone, Re. Citizen Petition from S. Varghese Supporting & Related Material Background Material 2016-12-29T05:00:00Z 2016 12     2016-12-29T17:34:12Z   0 0 090000648243acfb

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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;