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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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45 rows where docket_id = "FDA-2021-N-0002" sorted by posted_date descending

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document_type 3

  • Supporting & Related Material 40
  • Rule 4
  • Notice 1

posted_year 2

  • 2021 36
  • 2022 9

agency_id 1

  • FDA 45
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-N-0002-0045 FDA None FDA-2021-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Rule Final Rule 2022-03-29T04:00:00Z 2022 3 2022-03-29T04:00:00Z   2022-03-29T13:38:19Z 2022-06395 0 0 0900006484feb0a8
FDA-2021-N-0002-0044 FDA None FDA-2021-N-0002 New Animal Drugs; Withdrawal of Approval of New Animal Drug Application Notice Withdrawal 2022-02-28T05:00:00Z 2022 2 2022-02-28T05:00:00Z   2022-02-28T16:29:16Z 2022-03539 0 0 0900006484fab908
FDA-2021-N-0002-0043 FDA None FDA-2021-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor Rule Final Rule 2022-02-28T05:00:00Z 2022 2 2022-02-28T05:00:00Z   2022-02-28T16:22:14Z 2022-03538 0 0 0900006484fab3c6
FDA-2021-N-0002-0037 FDA None FDA-2021-N-0002 FOI Summary oA 200-708 approved August 2 2021 Supporting & Related Material Background Material 2022-02-25T05:00:00Z 2022 2     2022-02-25T13:45:46Z   0 0 0900006484fa0eea
FDA-2021-N-0002-0041 FDA None FDA-2021-N-0002 FOI Summary sN 141-063 approved August 19 2021 Supporting & Related Material Background Material 2022-02-25T05:00:00Z 2022 2     2022-02-25T13:46:01Z   0 0 0900006484fa0ef2
FDA-2021-N-0002-0042 FDA None FDA-2021-N-0002 FOI Summary oN 141-545 approved July 15 2021 Supporting & Related Material Background Material 2022-02-25T05:00:00Z 2022 2     2022-02-25T13:46:05Z   0 0 0900006484fa0ef5
FDA-2021-N-0002-0040 FDA None FDA-2021-N-0002 FOI Summary oA 200-709 approved August 18 2021 Supporting & Related Material Background Material 2022-02-25T05:00:00Z 2022 2     2022-02-25T13:45:57Z   0 0 0900006484fa0ef0
FDA-2021-N-0002-0038 FDA None FDA-2021-N-0002 FOI Summary sA 200-618 approved August 16 2021 Supporting & Related Material Background Material 2022-02-25T05:00:00Z 2022 2     2022-02-25T13:45:50Z   0 0 0900006484fa0eed
FDA-2021-N-0002-0039 FDA None FDA-2021-N-0002 FOI Summary oA 200-703 approved July 7 2021 Supporting & Related Material Background Material 2022-02-25T05:00:00Z 2022 2     2022-02-25T13:45:53Z   0 0 0900006484fa0eee
FDA-2021-N-0002-0029 FDA None FDA-2021-N-0002 FOI Summary sN 141-452 approved May 18 2021 RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address Supporting & Related Material Background Material 2021-11-08T05:00:00Z 2021 11     2021-11-08T14:51:01Z   0 0 0900006484e31b69
FDA-2021-N-0002-0032 FDA None FDA-2021-N-0002 FOI Summary oA 200-702 approved April 23 2021 RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address Supporting & Related Material Background Material 2021-11-08T05:00:00Z 2021 11     2021-11-08T14:51:19Z   0 0 0900006484e31b6c
FDA-2021-N-0002-0035 FDA None FDA-2021-N-0002 FOI Summary oN 141-543 approved June 1 2021 RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address Supporting & Related Material Background Material 2021-11-08T05:00:00Z 2021 11     2021-11-08T14:51:37Z   0 0 0900006484e356c9
FDA-2021-N-0002-0024 FDA None FDA-2021-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address Rule Final Rule 2021-11-08T05:00:00Z 2021 11 2021-11-08T05:00:00Z   2021-11-08T14:01:16Z 2021-24075 0 0 0900006484e35459
FDA-2021-N-0002-0027 FDA None FDA-2021-N-0002 FOI Summary oA 200-700 approved June 10 2021 RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address Supporting & Related Material Background Material 2021-11-08T05:00:00Z 2021 11     2021-11-08T14:50:45Z   0 0 0900006484e31b67
FDA-2021-N-0002-0036 FDA None FDA-2021-N-0002 FOI Summary sN 140-269 approved May 25 2021 RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address Supporting & Related Material Background Material 2021-11-08T05:00:00Z 2021 11     2021-11-08T14:51:43Z   0 0 0900006484e356ca
FDA-2021-N-0002-0028 FDA None FDA-2021-N-0002 FOI Summary sN 128-620 approved June 14 2021 RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address Supporting & Related Material Background Material 2021-11-08T05:00:00Z 2021 11     2021-11-08T14:50:51Z   0 0 0900006484e31b68
FDA-2021-N-0002-0026 FDA None FDA-2021-N-0002 FOI Summary oA 200-697 approved April 5 2021 RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address Supporting & Related Material Background Material 2021-11-08T05:00:00Z 2021 11     2021-11-08T14:50:39Z   0 0 0900006484e31b66
FDA-2021-N-0002-0030 FDA None FDA-2021-N-0002 FOI Summary sN 141-528 approved April 12 2021 RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address Supporting & Related Material Background Material 2021-11-08T05:00:00Z 2021 11     2021-11-08T14:51:07Z   0 0 0900006484e31b6a
FDA-2021-N-0002-0031 FDA None FDA-2021-N-0002 FOI Summary oA 200-706 approved June 28 2021 RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address Supporting & Related Material Background Material 2021-11-08T05:00:00Z 2021 11     2021-11-08T14:51:13Z   0 0 0900006484e31b6b
FDA-2021-N-0002-0033 FDA None FDA-2021-N-0002 FOI Summary sN 139-189 approved April 26 2021 RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address Supporting & Related Material Background Material 2021-11-08T05:00:00Z 2021 11     2021-11-08T14:51:25Z   0 0 0900006484e31b6d
FDA-2021-N-0002-0025 FDA None FDA-2021-N-0002 FOI Summary oA 200-701 approved June 10 2021 RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address Supporting & Related Material Background Material 2021-11-08T05:00:00Z 2021 11     2021-11-08T14:50:04Z   0 0 0900006484e31b65
FDA-2021-N-0002-0034 FDA None FDA-2021-N-0002 FOI Summary oA 200-704 approved June 14 2021 RE New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address Supporting & Related Material Background Material 2021-11-08T05:00:00Z 2021 11     2021-11-08T14:51:31Z   0 0 0900006484e356c8
FDA-2021-N-0002-0023 FDA None FDA-2021-N-0002 FOI Summary cN 141-526 approved January 11 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:52Z   0 0 0900006484de3d1c
FDA-2021-N-0002-0006 FDA None FDA-2021-N-0002 FOI Summary oA 200-675 approved January 12 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:51Z   0 0 0900006484de3d16
FDA-2021-N-0002-0010 FDA None FDA-2021-N-0002 FOI Summary sN 141-336 approved January 7 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:52Z   0 0 0900006484de3d1b
FDA-2021-N-0002-0016 FDA None FDA-2021-N-0002 FOI Summary oN 141-539 approved January 15 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:54Z   0 0 0900006484de3d22
FDA-2021-N-0002-0017 FDA None FDA-2021-N-0002 FOI Summary sN 132-872 approved March 24 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:54Z   0 0 0900006484de3d23
FDA-2021-N-0002-0018 FDA None FDA-2021-N-0002 FOI Summary oN 141-531 approved March 19 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:54Z   0 0 0900006484de3d24
FDA-2021-N-0002-0020 FDA None FDA-2021-N-0002 FOI Summary oA 200-683 approved February 1 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:55Z   0 0 0900006484de3d30
FDA-2021-N-0002-0004 FDA None FDA-2021-N-0002 FOI Summary oA 200-677 approved January 12 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:51Z   0 0 0900006484de3d14
FDA-2021-N-0002-0008 FDA None FDA-2021-N-0002 FOI Summary oA 200-657 approved February 18 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:51Z   0 0 0900006484de3d18
FDA-2021-N-0002-0011 FDA None FDA-2021-N-0002 FOI Summary oA 200-699 approved March 11 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:53Z   0 0 0900006484de3d1d
FDA-2021-N-0002-0015 FDA None FDA-2021-N-0002 FOI Summary oA 200-685 approved February 1 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:54Z   0 0 0900006484de3d21
FDA-2021-N-0002-0013 FDA None FDA-2021-N-0002 FOI Summary oA 200-678 approved January 12 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:53Z   0 0 0900006484de3d1f
FDA-2021-N-0002-0009 FDA None FDA-2021-N-0002 FOI Summary oA 200-684 approved February 1 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:52Z   0 0 0900006484de3d1a
FDA-2021-N-0002-0005 FDA None FDA-2021-N-0002 FOI Summary oA 200-676 approved January 12 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:51Z   0 0 0900006484de3d15
FDA-2021-N-0002-0002 FDA None FDA-2021-N-0002 FOI Summary oA 200-625 approved March 22 2021 re: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:50Z   0 0 0900006484de3d12
FDA-2021-N-0002-0007 FDA None FDA-2021-N-0002 FOI Summary cN 141-544 approved January 14 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:51Z   0 0 0900006484de3d17
FDA-2021-N-0002-0003 FDA None FDA-2021-N-0002 FOI Summary oA 200-666 approved February 18 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:51Z   0 0 0900006484de3d13
FDA-2021-N-0002-0022 FDA None FDA-2021-N-0002 FOI Summary oA 200-506 approved February 16 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:51Z   0 0 0900006484de3d19
FDA-2021-N-0002-0012 FDA None FDA-2021-N-0002 FOI Summary sA 200-466 approved February 8 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:53Z   0 0 0900006484de3d1e
FDA-2021-N-0002-0014 FDA None FDA-2021-N-0002 FOI Summary oN 141-540 Approved February 26 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:53Z   0 0 0900006484de3d20
FDA-2021-N-0002-0019 FDA None FDA-2021-N-0002 FOI Summary oN 141-530 approved March 15 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:55Z   0 0 0900006484de3d25
FDA-2021-N-0002-0021 FDA None FDA-2021-N-0002 FOI Summary oA 200-686 approved February 1 2021 RE: New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2021-10-22T04:00:00Z 2021 10     2021-10-26T14:36:55Z   0 0 0900006484de3d31
FDA-2021-N-0002-0001 FDA None FDA-2021-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Rule Final Rule 2021-10-20T04:00:00Z 2021 10 2021-10-20T04:00:00Z   2021-10-20T15:15:02Z 2021-22604 0 0 0900006484dcea30

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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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