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

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48 rows where docket_id = "FDA-2016-N-0002" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-N-0002-0048 FDA None FDA-2016-N-0002 Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction Notice Correction 2018-02-13T05:00:00Z 2018 2 2018-02-13T05:00:00Z   2018-02-13T15:05:16Z 2018-02926 0 0 0900006482f279da
FDA-2016-N-0002-0047 FDA None FDA-2016-N-0002 Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction Notice Correction 2017-07-18T04:00:00Z 2017 7 2017-07-18T04:00:00Z   2017-07-18T14:50:54Z 2017-15003 0 0 090000648293b5a7
FDA-2016-N-0002-0041 FDA None FDA-2016-N-0002 FOI Summary oA 200-589 approved December 21 2016 Supporting & Related Material Background Material 2017-03-01T05:00:00Z 2017 3     2017-03-01T17:59:40Z   0 0 09000064824e4a20
FDA-2016-N-0002-0042 FDA None FDA-2016-N-0002 FOI Summary oN 141-473 approved December 16 2016 Supporting & Related Material Background Material 2017-03-01T05:00:00Z 2017 3     2017-03-01T18:00:21Z   0 0 09000064824e4a21
FDA-2016-N-0002-0043 FDA None FDA-2016-N-0002 FOI Summary oN 141-474 approved November 10 2016 Supporting & Related Material Background Material 2017-03-01T05:00:00Z 2017 3     2017-03-01T18:00:55Z   0 0 09000064824e4dd9
FDA-2016-N-0002-0045 FDA None FDA-2016-N-0002 FOI Summary sN 141-443, approved November 16, 2016 Supporting & Related Material Background Material 2017-03-01T05:00:00Z 2017 3     2017-03-01T18:02:03Z   0 0 09000064824e4ddb
FDA-2016-N-0002-0044 FDA None FDA-2016-N-0002 FOI Summary oN 141-475 approved December 29 2016 Supporting & Related Material Background Material 2017-03-01T05:00:00Z 2017 3     2017-03-01T18:01:29Z   0 0 09000064824e4dda
FDA-2016-N-0002-0046 FDA None FDA-2016-N-0002 FOI Summary sN 141-452 approved December 12 2016 Supporting & Related Material Background Material 2017-03-01T05:00:00Z 2017 3     2017-03-01T18:02:38Z   0 0 09000064824e4ddc
FDA-2016-N-0002-0040 FDA None FDA-2016-N-0002 New Animal Drugs: Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name Rule Final Rule 2017-03-01T05:00:00Z 2017 3 2017-03-01T05:00:00Z   2017-03-01T15:12:02Z 2017-03930 0 0 09000064824e380d
FDA-2016-N-0002-0037 FDA None FDA-2016-N-0002 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications Rule Withdrawal 2017-02-24T05:00:00Z 2017 2 2017-02-24T05:00:00Z   2017-02-24T16:18:39Z 2017-03595 0 0 09000064824d99cf
FDA-2016-N-0002-0038 FDA None FDA-2016-N-0002 New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application Rule Withdrawal 2017-02-24T05:00:00Z 2017 2 2017-02-24T05:00:00Z   2017-02-24T16:23:09Z 2017-03678 0 0 09000064824d99d6
FDA-2016-N-0002-0039 FDA None FDA-2016-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor’s Address Rule Final Rule 2017-02-24T05:00:00Z 2017 2 2017-02-24T05:00:00Z   2017-02-24T16:27:30Z 2017-03677 0 0 09000064824d9ac7
FDA-2016-N-0002-0036 FDA None FDA-2016-N-0002 New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications Rule Final Rule 2017-02-24T05:00:00Z 2017 2 2017-02-24T05:00:00Z   2017-02-24T16:12:09Z 2017-03596 0 0 09000064824d9933
FDA-2016-N-0002-0035 FDA None FDA-2016-N-0002 Abbott Laboratories, et al.; Withdrawal of Approval of Four New Drug Applications and Two Abbreviated New Drug Applications Notice Withdrawal 2016-12-29T05:00:00Z 2016 12 2016-12-29T05:00:00Z   2016-12-29T15:02:22Z 2016-31625 0 0 090000648243d2a9
FDA-2016-N-0002-0034 FDA None FDA-2016-N-0002 Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications Rule Final Rule 2016-12-27T05:00:00Z 2016 12 2016-12-27T05:00:00Z   2016-12-27T15:20:22Z 2016-31084 0 0 0900006482437617
FDA-2016-N-0002-0033 FDA None FDA-2016-N-0002 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications Rule Withdrawal 2016-12-27T05:00:00Z 2016 12 2016-12-27T05:00:00Z   2016-12-27T14:40:37Z 2016-31082 0 0 09000064824374ac
FDA-2016-N-0002-0032 FDA None FDA-2016-N-0002 New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications Rule Final Rule 2016-12-27T05:00:00Z 2016 12 2016-12-27T05:00:00Z   2016-12-27T13:37:48Z 2016-31083 0 0 090000648243727b
FDA-2016-N-0002-0031 FDA None FDA-2016-N-0002 Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications Notice Withdrawal 2016-10-04T04:00:00Z 2016 10 2016-10-04T04:00:00Z   2016-10-04T16:14:57Z 2016-23893 0 0 0900006482291438
FDA-2016-N-0002-0030 FDA None FDA-2016-N-0002 New Animal Drugs: Approval of New Animal Drug Applications; Change of Sponsor's Address Rule Final Rule 2016-09-30T04:00:00Z 2016 9 2016-09-30T04:00:00Z   2016-09-30T13:43:41Z 2016-23230 0 0 0900006482284ad3
FDA-2016-N-0002-0029 FDA None FDA-2016-N-0002 New Animal Drugs for Use in Animal Feeds: Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine Rule Final Rule 2016-09-14T04:00:00Z 2016 9 2016-09-14T04:00:00Z   2016-09-14T13:59:59Z 2016-21985 0 0 090000648220a1e1
FDA-2016-N-0002-0028 FDA None FDA-2016-N-0002 Withdrawal of Approval of Part of a New Animal Drug Application; Chlortetracycline, Procaine Penicillin, and Sulfamethazine Notice Withdrawal 2016-09-14T04:00:00Z 2016 9 2016-09-14T04:00:00Z   2016-09-14T13:36:10Z 2016-21984 0 0 0900006482209c71
FDA-2016-N-0002-0019 FDA None FDA-2016-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's Address Rule Correction 2016-08-29T04:00:00Z 2016 8 2016-08-29T04:00:00Z   2016-08-29T15:36:17Z 2016-19914 0 0 09000064821a8156
FDA-2016-N-0002-0027 FDA None FDA-2016-N-0002 FOI Summary oA 200-596, approved May 24, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-08-29T04:00:00Z 2016 8     2016-08-29T16:11:19Z   0 0 09000064821a95b5
FDA-2016-N-0002-0026 FDA None FDA-2016-N-0002 FOI Summary oN 141-463, approved May 17, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-08-29T04:00:00Z 2016 8     2016-08-29T16:08:53Z   0 0 09000064821a95b4
FDA-2016-N-0002-0020 FDA None FDA-2016-N-0002 EA oN 141-439, approved May 2, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-08-29T04:00:00Z 2016 8     2016-08-29T15:55:41Z   0 0 09000064821a95ae
FDA-2016-N-0002-0018 FDA None FDA-2016-N-0002 New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application Rule Withdrawal 2016-08-29T04:00:00Z 2016 8 2016-08-29T04:00:00Z   2016-08-29T15:26:57Z 2016-19915 0 0 09000064821a7b65
FDA-2016-N-0002-0022 FDA None FDA-2016-N-0002 FOI Summary oA 200-587, approved June 20, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-08-29T04:00:00Z 2016 8     2016-08-29T15:54:56Z   0 0 09000064821a95b0
FDA-2016-N-0002-0021 FDA None FDA-2016-N-0002 FOI Summary oA 200-536, approved May 17, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-08-29T04:00:00Z 2016 8     2016-08-29T15:56:15Z   0 0 09000064821a95af
FDA-2016-N-0002-0024 FDA None FDA-2016-N-0002 FOI Summary oN 141-439, approved May 2, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-08-29T04:00:00Z 2016 8     2016-08-29T16:04:28Z   0 0 09000064821a95b2
FDA-2016-N-0002-0025 FDA None FDA-2016-N-0002 FOI Summary oN 141-457, approved May 16, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-08-29T04:00:00Z 2016 8     2016-08-29T16:06:08Z   0 0 09000064821a95b3
FDA-2016-N-0002-0023 FDA None FDA-2016-N-0002 FOI Summary oA 200-596, approved May 24, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-08-29T04:00:00Z 2016 8     2016-08-29T16:03:00Z   0 0 09000064821a95b1
FDA-2016-N-0002-0017 FDA None FDA-2016-N-0002 Finding of No Significant Impact (FONSI) for IMRESTOR (pegbovigrastim injection) in Dairy Cattle Supporting & Related Material Background Material 2016-06-08T04:00:00Z 2016 6     2016-06-13T21:06:34Z   0 0 0900006482021116
FDA-2016-N-0002-0012 FDA None FDA-2016-N-0002 New Animal Drugs: Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship Rule Final Rule 2016-06-08T04:00:00Z 2016 6 2016-06-08T04:00:00Z   2016-06-08T14:03:11Z 2016-13517 0 0 090000648201e0ff
FDA-2016-N-0002-0014 FDA None FDA-2016-N-0002 FREEDOM OF INFORMATION SUMMARY ORIGINAL NEW ANIMAL DRUG APPLICATION NADA 141-392 IMRESTOR Supporting & Related Material Background Material 2016-06-08T04:00:00Z 2016 6     2016-06-13T21:06:14Z   0 0 0900006482021113
FDA-2016-N-0002-0013 FDA None FDA-2016-N-0002 Environmental Assessment of PEGylated bovine granulocyte colony stimulating factor (PEG bG-CSF) for Dairy Cows (USA) Supporting & Related Material Background Material 2016-06-08T04:00:00Z 2016 6     2016-06-13T21:06:06Z   0 0 0900006482021112
FDA-2016-N-0002-0015 FDA None FDA-2016-N-0002 FREEDOM OF INFORMATION SUMMARY ORIGINAL NEW ANIMAL DRUG APPLICATION NADA 141-455 GALLIPRANT Supporting & Related Material Background Material 2016-06-08T04:00:00Z 2016 6     2016-06-13T21:06:21Z   0 0 0900006482021114
FDA-2016-N-0002-0016 FDA None FDA-2016-N-0002 FREEDOM OF INFORMATION SUMMARY ORIGINAL NEW ANIMAL DRUG APPLICATION NADA 141-460 AIVLOSIN 17% Tylvalosin Type A Medicated Article Swine Supporting & Related Material Background Material 2016-06-08T04:00:00Z 2016 6     2016-06-13T21:06:27Z   0 0 0900006482021115
FDA-2016-N-0002-0011 FDA None FDA-2016-N-0002 New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application Rule Withdrawal 2016-06-08T04:00:00Z 2016 6 2016-06-08T04:00:00Z   2016-06-08T13:29:59Z 2016-13518 0 0 090000648201df5b
FDA-2016-N-0002-0010 FDA None FDA-2016-N-0002 New Animal Drugs: Approval of New Animal Drug Applications; Changes of Sponsorship; Correction Rule Final Rule 2016-04-28T04:00:00Z 2016 4 2016-04-28T04:00:00Z   2016-04-28T16:16:35Z 2016-09865 0 0 0900006481f94e7f
FDA-2016-N-0002-0007 FDA None FDA-2016-N-0002 FOI Summary NADA 141-263 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-04-18T04:00:00Z 2016 4     2016-05-05T22:45:37Z   0 0 0900006481f71386
FDA-2016-N-0002-0001 FDA None FDA-2016-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Rule Correction 2016-04-18T04:00:00Z 2016 4 2016-04-18T04:00:00Z   2016-04-18T16:03:25Z 2016-08827 0 0 0900006481f705dc
FDA-2016-N-0002-0009 FDA None FDA-2016-N-0002 FONSI 141-449 SAFE-GUARD AQUASOL (fenbendazole oral suspension) in Swine except for nursing piglets re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-04-18T04:00:00Z 2016 4     2016-05-05T22:45:55Z   0 0 0900006481f7139d
FDA-2016-N-0002-0004 FDA None FDA-2016-N-0002 FOI Summary NADA 141-444 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-04-18T04:00:00Z 2016 4     2016-05-05T22:45:11Z   0 0 0900006481f710c4
FDA-2016-N-0002-0005 FDA None FDA-2016-N-0002 FOI Summary NADA 141-448 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-04-18T04:00:00Z 2016 4     2016-05-05T22:45:22Z   0 0 0900006481f710c5
FDA-2016-N-0002-0008 FDA None FDA-2016-N-0002 FOI Summary NADA 141-449 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-04-18T04:00:00Z 2016 4     2016-05-05T22:45:46Z   0 0 0900006481f71389
FDA-2016-N-0002-0002 FDA None FDA-2016-N-0002 Environmental Assessment re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-04-18T04:00:00Z 2016 4     2016-05-05T22:44:59Z   0 0 0900006481f710be
FDA-2016-N-0002-0006 FDA None FDA-2016-N-0002 FOI Summary NADA 141-452 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-04-18T04:00:00Z 2016 4     2016-05-05T22:45:29Z   0 0 0900006481f71323
FDA-2016-N-0002-0003 FDA None FDA-2016-N-0002 FOI Original Abbreviated New Animal Drug Application re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship Supporting & Related Material Background Material 2016-04-18T04:00:00Z 2016 4     2016-05-05T22:44:52Z   0 0 0900006481f710c3

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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;