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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

18 rows where docket_id = "FDA-2014-N-0002" and posted_year = 2015 sorted by posted_date descending

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posted_year 1

  • 2015 · 18 ✖

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2014-N-0002-0084 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-512 TRIAMULOX tiamulin hydrogen fumarate, 12.3% Liquid Concentrate Swine re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Supporting & Related Material Background Material 2015-03-17T04:00:00Z 2015 3     2015-03-17T13:58:43Z   0 0 0900006481a45f51
FDA-2014-N-0002-0081 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-276 ZILMAX plus RUMENSIN plus TYLAN (zilpaterol hydrochloride 4.8%; monensin, USP; and tylosin phosphate) Type A Medicated Articles For Use in the Manufacture of Type B and C Medicated Feeds Cattle Fed in Confinement for Slaughter re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T14:37:57Z   0 0 0900006481a45f5c
FDA-2014-N-0002-0071 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-522 Carprofen Sterile Injectable Solution carprofen Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T12:57:49Z   0 0 0900006481971dae
FDA-2014-N-0002-0075 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-575 Carprofen Chewable Tablets Carprofen Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T14:37:20Z   0 0 0900006481a45f53
FDA-2014-N-0002-0074 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-573 Dexmedetomidine HCl dexmedetomidine hydrochloride Sterile Injectable Solution Dogs and cats re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T14:37:12Z   0 0 0900006481a45f52
FDA-2014-N-0002-0077 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-034 GAINPRO bambermycins Type A Medicated Article to be used in the manufacture of Type C Medicated Feeds Pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers) re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T14:37:33Z   0 0 0900006481a45f55
FDA-2014-N-0002-0078 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-068 BAYTRIL 100 Injectable Solution Enrofloxacin Swine re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T14:37:39Z   0 0 0900006481a45f59
FDA-2014-N-0002-0079 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-232 SIMPLICEF Cefpodoxime proxetil Chewable tablets Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T14:37:45Z   0 0 0900006481a45f5a
FDA-2014-N-0002-0082 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-349 DRAXXIN 25 Injectable Solution Tulathromycin Injection Cattle (suckling calves, dairy calves, and veal calves) re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T14:38:04Z   0 0 0900006481a45f5d
FDA-2014-N-0002-0070 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-244 DRAXXIN Tulathromycin Injectable Solution Cattle suckling calves dairy calves and veal calves re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T12:57:42Z   0 0 0900006481971d5e
FDA-2014-N-0002-0072 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-581 FLUNAZINE flunixin meglumine Paste Horses re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T12:57:58Z   0 0 0900006481971db0
FDA-2014-N-0002-0076 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-437 OSURNIA florfenicol, terbinafine, betamethasone acetate Otic gel Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T14:37:27Z   0 0 0900006481a45f54
FDA-2014-N-0002-0080 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-258 ZILMAX Zilpaterol Hydrochloride 4.8% Type A medicated article to be used in the manufacture of Type B and C medicated feeds Cattle fed in confinement for slaughter re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T14:37:51Z   0 0 0900006481a45f5b
FDA-2014-N-0002-0073 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-510 DERACIN (chlortetracycline) Type A Medicated Article Cattle, Swine, Sheep, Turkeys, Chickens, Ducks, and Psittacine Birds re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T14:37:03Z   0 0 0900006481a45f50
FDA-2014-N-0002-0068 FDA None FDA-2014-N-0002 Freedom of Information Summary ORIGINAL NEW ANIMAL DRUG APPLICATION NADA 141-430 STAFAC and COBAN Virginiamycin and Monensin Type A Medicated Articles to be Used in the Manufacture of Type C Medicated Feeds Broiler Chickens re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T12:57:31Z   0 0 09000064819718df
FDA-2014-N-0002-0083 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 034-267 GENTOCIN DURAFILM (Gentamicin Sulfate and Betamethasone) Sterile Ophthalmic Solution re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T14:38:09Z   0 0 0900006481a45f5e
FDA-2014-N-0002-0069 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-540 Meloxicam Solution for Injection meloxicam Dogs and Cats re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications Supporting & Related Material Freedom of Information Summary 2015-03-16T04:00:00Z 2015 3     2015-03-16T12:57:36Z   0 0 0900006481971d58
FDA-2014-N-0002-0067 FDA None FDA-2014-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Rule Final Rule 2015-03-13T04:00:00Z 2015 3 2015-03-13T04:00:00Z   2015-03-13T17:08:47Z 2015-05644 0 0 0900006481a42753

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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;