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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-1999-D-0049" sorted by posted_date descending

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

posted_year 2

  • 2004 3
  • 1999 1

document_type 1

  • Notice 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-1999-D-0049-0004 FDA Draft Guidance for Ind - Changes to an Approved NDA or ANDA FDA-1999-D-0049 Guidance for Industry on Changes to an Approved New Drug Application or Abbreviated New Drug Application; Availability; Correction Notice Correction 2004-04-27T04:00:00Z 2004 4 2004-04-23T04:00:00Z   2025-08-05T16:12:58Z 04-9324 0 0 09000064804a6057
FDA-1999-D-0049-0003 FDA Draft Guidance for Ind - Changes to an Approved NDA or ANDA FDA-1999-D-0049 Guidance for Industry on Changes to an Approved NDA or ANDA; Availability Notice Notice of Data Availability 2004-04-08T04:00:00Z 2004 4 2004-04-07T04:00:00Z   2025-08-05T16:08:04Z 04-7533 0 0 09000064804a6056
FDA-1999-D-0049-0002 FDA Draft Guidance for Ind - Changes to an Approved NDA or ANDA FDA-1999-D-0049 Guidance for Industry Changes to an Approved NDA or ANDA Notice Guidance 2004-04-08T04:00:00Z 2004 4     2024-11-07T21:52:49Z   1 0 09000064804a6055
FDA-1999-D-0049-0001 FDA Draft Guidance for Ind - Changes to an Approved NDA or ANDA FDA-1999-D-0049 Changes to an Approved NDA or ANDA; Proposed Rule and Draft Companion Guidance; Public Meeting Notice NM-Notice of Meeting 1999-08-05T00:00:00Z 1999 8     2025-05-21T22:37:52Z   0 0 09000064804a6017

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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    withdrawn INTEGER,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);
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