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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

4 rows where docket_id = "FDA-2019-P-3877" sorted by posted_date descending

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

document_type 2

  • Other 3
  • Notice 1

posted_year 1

  • 2019 4

agency_id 1

  • FDA 4
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-P-3877-0003 FDA None FDA-2019-P-3877 Determination That GLUCOPHAGE (Metformin Hydrochloride) Oral Tablets, 500 Milligrams, 850 Milligrams, and 1 Gram, and GLUCOPHAGE XR (Metformin Hydrochloride) Oral Extended-Release Tablets, 500 Milligrams and 750 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2019-12-31T05:00:00Z 2019 12 2019-12-31T05:00:00Z   2019-12-31T14:31:28Z 2019-28270 0 0 090000648425d320
FDA-2019-P-3877-0004 FDA None FDA-2019-P-3877 Response Letter to Harman Finochem Limited Updated from FDA CDER Other Agency Response 2019-12-31T05:00:00Z 2019 12 2019-12-31T05:00:00Z   2019-12-31T19:24:26Z   0 0 090000648425fa9c
FDA-2019-P-3877-0002 FDA None FDA-2019-P-3877 Acknowledgment Letter from FDA DMS to Harman Finochem Limited Other Acknowledgement Letter/Receipt 2019-08-20T04:00:00Z 2019 8 2019-08-20T04:00:00Z   2019-08-20T15:56:54Z   0 0 0900006483e6b6a3
FDA-2019-P-3877-0001 FDA None FDA-2019-P-3877 Citizen Petition from Harman Finochem Limited Other Citizen Petition 2019-08-20T04:00:00Z 2019 8 2019-08-20T04:00:00Z   2024-11-12T23:07:07Z   1 0 0900006483e5c0a8

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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    withdrawn INTEGER,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;
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