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

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59 rows where docket_id = "FDA-2013-N-0002" sorted by posted_date descending

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posted_year 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2013-N-0002-0057 FDA None FDA-2013-N-0002 Pulmotil AC (aqueous tilmicosin) Environmental Assessment for the Use of Pulmotil AC to Control Swine Respiratory Disease Other Background Material 2014-04-09T04:00:00Z 2014 4 2014-04-09T04:00:00Z   2014-04-09T12:45:38Z   0 0 09000064816aa8f6
FDA-2013-N-0002-0058 FDA None FDA-2013-N-0002 ENVIRONMENTAL ASSESSMENT for AQUAFLOR (Florfenicol) 50% Type A Medicated Article Other Background Material 2014-04-09T04:00:00Z 2014 4 2014-04-09T04:00:00Z   2014-04-09T12:51:55Z   0 0 09000064816aa8f7
FDA-2013-N-0002-0056 FDA None FDA-2013-N-0002 Finding of No Significant Impact FONSI For AQUAFLOR Florfenicol 50 percent Type A Medicated Article Other Background Material 2014-04-09T04:00:00Z 2014 4 2014-04-09T04:00:00Z   2014-04-09T12:40:34Z   0 0 09000064816aa8f5
FDA-2013-N-0002-0059 FDA None FDA-2013-N-0002 Finding of No Significant Impact (FONSI) for PULMOTIL AC Aqueous Concentrate (Tilmicosin) in Swine for the Control of Swine Respiratory Disease Other Background Material 2014-04-09T04:00:00Z 2014 4 2014-04-09T04:00:00Z   2014-04-09T12:55:59Z   0 0 09000064816aa8f8
FDA-2013-N-0002-0052 FDA None FDA-2013-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-361 PULMOTIL AC Tilmicosin Phosphate Aqueous Concentrate Swine Supporting & Related Material Freedom of Information Summary 2014-04-08T04:00:00Z 2014 4     2014-04-08T16:29:38Z   0 0 09000064816a892c
FDA-2013-N-0002-0053 FDA None FDA-2013-N-0002 FREEDOM OF INFORMATION SUMMARY NADA141-420 TILDREN tiludronate disodium Powder for injection Horse Supporting & Related Material Freedom of Information Summary 2014-04-08T04:00:00Z 2014 4     2014-04-08T16:32:40Z   0 0 09000064816a892d
FDA-2013-N-0002-0055 FDA None FDA-2013-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 130-185 AMPROL 25% and FLAVOMYCIN Amprolium and Bambermycins Supporting & Related Material Freedom of Information Summary 2014-04-08T04:00:00Z 2014 4     2014-04-08T16:36:57Z   0 0 09000064816a8b80
FDA-2013-N-0002-0054 FDA None FDA-2013-N-0002 FREEDOM OF INFORMATION SUMMARY Application Number 141-422 PACCAL VET-CA1 Paclitaxel for injection Powder for Injection Dog Supporting & Related Material Freedom of Information Summary 2014-04-08T04:00:00Z 2014 4     2014-04-08T16:35:08Z   0 0 09000064816a892e
FDA-2013-N-0002-0051 FDA None FDA-2013-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-246 AQUAFLOR Florfenicol Supporting & Related Material Freedom of Information Summary 2014-04-08T04:00:00Z 2014 4     2014-04-08T16:22:29Z   0 0 09000064816a892b
FDA-2013-N-0002-0050 FDA None FDA-2013-N-0002 New Animal Drugs; Amprolium; Bambermycins; Ceftiofur; Deslorelin; Florfenicol; Florfenicol and Flunixin; Paclitaxel; Phenylbutazone; Pimobendan; Salinomycin; Tilmicosin; Tiludronate; Change of Sponsor Rule Final Rule 2014-04-01T04:00:00Z 2014 4 2014-04-01T04:00:00Z   2014-04-01T13:05:54Z 2014-07220 0 0 0900006481694311
FDA-2013-N-0002-0048 FDA None FDA-2013-N-0002 Current Good Manufacturing Practice for Medicated Feeds Rule Final Rule 2014-01-23T05:00:00Z 2014 1 2014-01-23T05:00:00Z   2014-01-23T17:39:42Z 2014-01299 0 0 090000648151cdd1
FDA-2013-N-0002-0047 FDA None FDA-2013-N-0002 Withdrawal of Approval of New Animal Drug Applications; Argent Laboratories; Formalin; Tricaine Methanesulfonate Rule Final Rule 2014-01-16T05:00:00Z 2014 1 2014-01-16T05:00:00Z   2014-01-16T15:17:57Z 2014-00721 0 0 090000648150d6c6
FDA-2013-N-0002-0046 FDA None FDA-2013-N-0002 Withdrawal of Approval of New Animal Drug Applications; Argent Laboratories; Formalin; Tricaine Methanesulfonate Rule Withdrawal 2014-01-16T05:00:00Z 2014 1 2014-01-16T05:00:00Z   2014-01-16T15:01:12Z 2014-00722 0 0 090000648150d714
FDA-2013-N-0002-0045 FDA None FDA-2013-N-0002 New Animal Drugs for Use in Animal Feeds; Bambermycins; Correction Rule Correction 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T15:28:01Z 2013-31184 0 0 09000064814e1974
FDA-2013-N-0002-0049 FDA None FDA-2013-N-0002 Approvals of New Animal Drug Applications Withdrawals Roxarsone Rule Final Rule 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z   2014-01-25T23:25:40Z 2013-30837 0 0 09000064814de405
FDA-2013-N-0002-0044 FDA None FDA-2013-N-0002 Withdrawal of Approval of New Animal Drug Applications; Roxarsone Rule Final Rule 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z   2013-12-27T15:39:48Z 2013-30838 0 0 09000064814de527
FDA-2013-N-0002-0043 FDA None FDA-2013-N-0002 New Animal Drugs for Use in Animal Feeds; Bambermycins Rule Final Rule 2013-12-16T05:00:00Z 2013 12 2013-12-16T05:00:00Z   2013-12-16T17:30:57Z 2013-29810 0 0 09000064814c1cc8
FDA-2013-N-0002-0042 FDA None FDA-2013-N-0002 New Animal Drugs: Hyaluronate Sodium; Hydrogen Peroxide; Imidacloprid and Moxidectin; Change of Sponsor Rule Final Rule 2013-12-09T05:00:00Z 2013 12     2013-12-10T11:17:01Z 2013-29234 0 0 09000064814b25e6
FDA-2013-N-0002-0041 FDA None FDA-2013-N-0002 Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid Rule Final Rule 2013-11-26T05:00:00Z 2013 11 2013-11-26T05:00:00Z   2013-11-26T14:21:13Z 2013-28256 0 0 09000064814989b3
FDA-2013-N-0002-0040 FDA None FDA-2013-N-0002 Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid Notice General Notice 2013-11-26T05:00:00Z 2013 11 2013-11-26T05:00:00Z   2013-11-26T14:17:06Z 2013-28255 0 0 0900006481498795
FDA-2013-N-0002-0039 FDA None FDA-2013-N-0002 Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone Rule Final Rule 2013-11-22T05:00:00Z 2013 11 2013-11-22T05:00:00Z   2013-11-22T14:42:39Z 2013-27917 0 0 0900006481491103
FDA-2013-N-0002-0038 FDA None FDA-2013-N-0002 Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone Notice General Notice 2013-11-22T05:00:00Z 2013 11 2013-11-22T05:00:00Z   2013-11-22T14:37:17Z 2013-27916 0 0 09000064814910b5
FDA-2013-N-0002-0036 FDA None FDA-2013-N-0002 Freedom of Information Summary NADA 095-735 RUMENSIN 90 Monensin Supporting & Related Material Freedom of Information Summary 2013-11-05T05:00:00Z 2013 11     2013-11-05T17:24:32Z   0 0 09000064814711c6
FDA-2013-N-0002-0034 FDA None FDA-2013-N-0002 New Animal Drugs: Afoxolaner, Carprofen, Ceftiofur Hydrochloride, Monensin Rule Final Rule 2013-11-05T05:00:00Z 2013 11 2013-11-05T05:00:00Z   2013-11-05T16:41:31Z 2013-26473 0 0 0900006481470b65
FDA-2013-N-0002-0037 FDA None FDA-2013-N-0002 Freedom of Information Summary NADA 141-288 EXCENEL RTU EZ Ceftiofur Hydrochloride Supporting & Related Material Freedom of Information Summary 2013-11-05T05:00:00Z 2013 11     2013-11-05T17:34:49Z   0 0 0900006481471240
FDA-2013-N-0002-0035 FDA None FDA-2013-N-0002 Freedom of Information Summary NADA 141-406 NEXGARD Afoxolaner Chewable Tablet Supporting & Related Material Freedom of Information Summary 2013-11-05T05:00:00Z 2013 11     2013-11-05T17:00:27Z   0 0 09000064814706c5
FDA-2013-N-0002-0028 FDA None FDA-2013-N-0002 Freedom of Information Summary NADA 139-237 Lactating Dairy Cows Supporting & Related Material Freedom of Information Summary 2013-10-25T04:00:00Z 2013 10     2013-10-25T13:44:45Z   0 0 090000648145e676
FDA-2013-N-0002-0030 FDA None FDA-2013-N-0002 Freedom of Information Summary NADA 141-360 EQUISUL-SDT Sulfadiazine/Trimethoprim Horses Supporting & Related Material Freedom of Information Summary 2013-10-25T04:00:00Z 2013 10     2013-10-25T14:04:49Z   0 0 090000648145e7f0
FDA-2013-N-0002-0032 FDA None FDA-2013-N-0002 Freedom of Information Summary ANADA 200-542 ENGAIN 9 and ENGAIN 5 Ractopamine Hydrochloride Finishing Swine Supporting & Related Material Freedom of Information Summary 2013-10-25T04:00:00Z 2013 10     2013-10-25T14:32:31Z   0 0 090000648145e8f7
FDA-2013-N-0002-0033 FDA None FDA-2013-N-0002 Freedom of Information Summary ANADA 200-548 ACTOGAIN 45 Ractopamine Hydrochloride Cattle fed in confinement for slaughter Supporting & Related Material Freedom of Information Summary 2013-10-25T04:00:00Z 2013 10     2013-10-25T14:31:20Z   0 0 090000648145e8fc
FDA-2013-N-0002-0029 FDA None FDA-2013-N-0002 Freedom of Information Summary NADA 141-349 DRAXXIN 25 Injectable Solution, Tulathromycin, Swine Supporting & Related Material Freedom of Information Summary 2013-10-25T04:00:00Z 2013 10     2013-10-25T13:58:47Z   0 0 090000648145e677
FDA-2013-N-0002-0031 FDA None FDA-2013-N-0002 New Animal Drugs; Change of Sponsor: Gonadorelin, Ivermectin, Ractopamine, Trimethoprim and Sulfadiazine Suspension, Tulathromycin Rule Final Rule 2013-10-25T04:00:00Z 2013 10 2013-10-25T04:00:00Z   2013-10-25T14:19:29Z 2013-25172 0 0 090000648145feec
FDA-2013-N-0002-0027 FDA None FDA-2013-N-0002 Freedom of Information Summary ANADA 200-550 MELOXIDYL Meloxicam Supporting & Related Material Freedom of Information Summary 2013-09-20T04:00:00Z 2013 9     2013-09-20T14:17:02Z   0 0 090000648142d5dd
FDA-2013-N-0002-0026 FDA None FDA-2013-N-0002 Freedom of Information Summary ANADA 200-514 BOVIPROL 9.6% Oral Solution Amprolium Cattle/Calves Supporting & Related Material Freedom of Information Summary 2013-09-20T04:00:00Z 2013 9     2013-09-20T14:03:03Z   0 0 090000648142d5dc
FDA-2013-N-0002-0025 FDA None FDA-2013-N-0002 Oral Dosage Form New Animal Drugs: Amprolium; Meloxicam Rule Final Rule 2013-09-17T04:00:00Z 2013 9 2013-09-17T04:00:00Z   2013-09-17T15:23:49Z 2013-22523 0 0 09000064814276a4
FDA-2013-N-0002-0024 FDA None FDA-2013-N-0002 New Animal Drugs: Carprofen; Enrofloxacin; Florfenicol; Tildipirosin; Zilpaterol Rule Final Rule 2013-08-27T04:00:00Z 2013 8 2013-08-27T04:00:00Z   2013-12-10T11:40:18Z 2013-20538 0 0 09000064813c6a82
FDA-2013-N-0002-0022 FDA None FDA-2013-N-0002 Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin Notice Withdrawal 2013-08-23T04:00:00Z 2013 8 2013-08-23T04:00:00Z   2013-08-23T15:35:16Z 2013-20615 0 0 09000064813c11f6
FDA-2013-N-0002-0023 FDA None FDA-2013-N-0002 Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin Rule Final Rule 2013-08-23T04:00:00Z 2013 8 2013-08-23T04:00:00Z   2013-08-23T15:22:26Z 2013-20616 0 0 09000064813c1175
FDA-2013-N-0002-0021 FDA None FDA-2013-N-0002 New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection Rule Final Rule 2013-07-24T04:00:00Z 2013 7 2013-07-24T04:00:00Z   2013-07-24T14:40:15Z 2013-17754 0 0 0900006481379e58
FDA-2013-N-0002-0019 FDA None FDA-2013-N-0002 Freedom of Information Summary NADA 141-345 APOQUEL (oclacitinib tablet) Supporting & Related Material Freedom of Information Summary 2013-07-15T04:00:00Z 2013 7     2013-07-15T15:48:56Z   0 0 0900006481366402
FDA-2013-N-0002-0018 FDA None FDA-2013-N-0002 Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; Zilpaterol Rule Final Rule 2013-07-15T04:00:00Z 2013 7 2013-07-15T04:00:00Z   2013-07-15T15:40:23Z 2013-16258 0 0 09000064813666f8
FDA-2013-N-0002-0020 FDA None FDA-2013-N-0002 Freedom of Information Summary ANADA 200-544 ZILMAX plus RUMENSIN plus TYLOVET 100 plus MGA Supporting & Related Material Reference (internal unless indicated) 2013-07-15T04:00:00Z 2013 7     2013-07-15T15:56:17Z   0 0 0900006481366403
FDA-2013-N-0002-0017 FDA None FDA-2013-N-0002 New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin; Correction Rule Correction 2013-06-05T04:00:00Z 2013 6 2013-06-05T04:00:00Z   2013-06-05T14:01:32Z 2013-13331 0 0 090000648130b953
FDA-2013-N-0002-0016 FDA None FDA-2013-N-0002 Freedom of Information Summary ANADA 200-551 Enrofloxacin Flavored Tablets Supporting & Related Material Freedom of Information Summary 2013-05-22T04:00:00Z 2013 5     2013-05-22T14:18:38Z   0 0 09000064812f25ab
FDA-2013-N-0002-0014 FDA None FDA-2013-N-0002 Oral Dosage Form New Animal Drugs; Clindamycin; Enrofloxacin Rule Final Rule 2013-05-22T04:00:00Z 2013 5 2013-05-22T04:00:00Z   2013-05-22T13:54:39Z 2013-12134 0 0 09000064812f2154
FDA-2013-N-0002-0015 FDA None FDA-2013-N-0002 Freedom of Information Summary ANADA 200-538 CLINDAMED Oral Drops Supporting & Related Material Freedom of Information Summary 2013-05-22T04:00:00Z 2013 5     2013-05-22T14:09:47Z   0 0 09000064812f2586
FDA-2013-N-0002-0013 FDA None FDA-2013-N-0002 New Animal Drugs; Change of Sponsor's Name and Address; Change of Sponsor Rule Final Rule 2013-05-13T04:00:00Z 2013 5 2013-05-13T04:00:00Z   2013-05-13T13:30:45Z 2013-11283 0 0 09000064812dfc63
FDA-2013-N-0002-0012 FDA None FDA-2013-N-0002 Freedom of Information Summary ANADA 200-535 Melengestrol acetate plus lasalocid sodium plus tylosin phosphate Supporting & Related Material Freedom of Information Summary 2013-04-30T04:00:00Z 2013 4     2013-04-30T14:12:34Z   0 0 09000064812ad2f7
FDA-2013-N-0002-0010 FDA None FDA-2013-N-0002 Freedom of Information Summary ANADA 200-532 MGA plus TYLOVET 100 Supporting & Related Material Freedom of Information Summary 2013-04-30T04:00:00Z 2013 4     2013-04-30T13:49:36Z   0 0 09000064812ad28f
FDA-2013-N-0002-0009 FDA None FDA-2013-N-0002 New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin Rule Final Rule 2013-04-30T04:00:00Z 2013 4 2013-04-30T04:00:00Z   2013-04-30T13:30:05Z 2013-10152 0 0 09000064812ad9a8
FDA-2013-N-0002-0011 FDA None FDA-2013-N-0002 Freedom of Information Summary ANADA 200-533 DECCOX plus RUMENSIN plus TYLOVET 100 (decoquinate plus monensin USP plus tylosin phosphate) Supporting & Related Material Reference (internal unless indicated) 2013-04-30T04:00:00Z 2013 4     2013-04-30T14:03:23Z   0 0 09000064812ad2f5
FDA-2013-N-0002-0008 FDA None FDA-2013-N-0002 New Animal Drugs: Change of Sponsor Rule Final Rule 2013-04-09T04:00:00Z 2013 4 2013-04-09T04:00:00Z   2013-04-09T14:02:58Z 2013-07542 0 0 0900006481289e2d
FDA-2013-N-0002-0005 FDA None FDA-2013-N-0002 Freedom of Information Summary re Abbreviated New Animal Drug Application ANADA 200-495 ENROFLOX 100 Enrofloxacin Injectable Solution Beef and Non-Lactating Dairy Cattle Swine Supporting & Related Material Freedom of Information Summary 2013-04-03T04:00:00Z 2013 4     2013-12-10T12:05:33Z   0 0 09000064812642ee
FDA-2013-N-0002-0007 FDA None FDA-2013-N-0002 Freedom of Information Summary re Abbreviated New Animal Drug Application ANADA 20TYLOVET 100 Tylosin Phosphate and RUMENSIN Monensin 200-531 Type Articles For Use in the Manufacture of Type B and Medicated Feeds Supporting & Related Material Freedom of Information Summary 2013-04-03T04:00:00Z 2013 4     2013-12-10T12:09:28Z   0 0 0900006481264a82
FDA-2013-N-0002-0004 FDA None FDA-2013-N-0002 New Animal Drugs: Enrofloxacin; Tilmicosin; Tylosin Rule Final Rule 2013-04-03T04:00:00Z 2013 4 2013-04-03T04:00:00Z   2013-04-03T15:12:51Z 2013-07571 0 0 0900006481263219
FDA-2013-N-0002-0006 FDA None FDA-2013-N-0002 Freedom of Information Summary re Abbreviated New Animal Drug Application ANADA 200-509 TILMOVET 90 Tilmicosin Phosphate Type A Medicated Article Supporting & Related Material Freedom of Information Summary 2013-04-03T04:00:00Z 2013 4     2013-12-10T12:11:23Z   0 0 0900006481264910
FDA-2013-N-0002-0003 FDA None FDA-2013-N-0002 Freedom of Information Summary ANADA 200-541 GONABREED Gonadorelin Acetate Injectable Solution Dairy Cattle Supporting & Related Material Freedom of Information Summary 2013-03-26T04:00:00Z 2013 3     2013-12-10T11:54:59Z   0 0 0900006481243b6a
FDA-2013-N-0002-0002 FDA None FDA-2013-N-0002 New Animal Drug Approvals: Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide Rule Final Rule 2013-03-25T04:00:00Z 2013 3 2013-03-25T04:00:00Z   2013-12-10T11:54:02Z 2013-06748 0 0 090000648124175f
FDA-2013-N-0002-0001 FDA None FDA-2013-N-0002 New Animal Drugs: Sponsor Changes Rule Final Rule 2013-03-22T04:00:00Z 2013 3 2013-03-22T04:00:00Z   2013-03-22T13:17:57Z 2013-06126 0 0 090000648123d536

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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;