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

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document_type 3

  • Supporting & Related Material 44
  • Rule 12
  • Notice 3

posted_year 1

  • 2015 · 59 ✖

agency_id 1

  • FDA 59
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-N-0002-0059 FDA None FDA-2015-N-0002 New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate Rule Final Rule 2015-12-22T05:00:00Z 2015 12 2015-12-22T05:00:00Z   2015-12-22T14:25:51Z 2015-32000 0 0 0900006481dc12f6
FDA-2015-N-0002-0057 FDA None FDA-2015-N-0002 New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of New Animal Drug Applications; Nitarsone Rule Withdrawal 2015-12-18T05:00:00Z 2015 12 2015-12-18T05:00:00Z   2015-12-18T14:31:28Z 2015-31828 0 0 0900006481db9730
FDA-2015-N-0002-0058 FDA None FDA-2015-N-0002 New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of New Animal Drug Applications; Nitarsone Rule Final Rule 2015-12-18T05:00:00Z 2015 12 2015-12-18T05:00:00Z   2015-12-18T14:34:22Z 2015-31827 0 0 0900006481db988a
FDA-2015-N-0002-0050 FDA None FDA-2015-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship Rule Final Rule 2015-12-09T05:00:00Z 2015 12 2015-12-09T05:00:00Z   2015-12-09T15:36:21Z 2015-31042 0 0 0900006481d9202e
FDA-2015-N-0002-0051 FDA None FDA-2015-N-0002 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications Rule Withdrawal 2015-12-09T05:00:00Z 2015 12 2015-12-09T05:00:00Z   2015-12-09T15:39:22Z 2015-31040 0 0 0900006481d92512
FDA-2015-N-0002-0053 FDA None FDA-2015-N-0002 Environmental Assessment Safe-Guard Aquasol for Chicken (20% Fenbendazole Suspension Supporting & Related Material Background Material 2015-12-09T05:00:00Z 2015 12     2015-12-09T15:53:03Z   0 0 0900006481d92b7b
FDA-2015-N-0002-0054 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-449 SAFE-GUARD AquaSol Fenbendazole oral suspension Broiler chickens, replacement chickens intended to become breeding chickens, and breeding chickens Supporting & Related Material Freedom of Information Summary 2015-12-09T05:00:00Z 2015 12     2015-12-09T15:55:42Z   0 0 0900006481d92b7d
FDA-2015-N-0002-0056 FDA None FDA-2015-N-0002 Finding of No Significant Impact (FONSI) for SAFE-GUARD AQUASOL (fenbendazole oral suspension) in Chickens Supporting & Related Material Background Material 2015-12-09T05:00:00Z 2015 12     2015-12-09T16:03:27Z   0 0 0900006481d92bb3
FDA-2015-N-0002-0052 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-440 CLARO Florfenicol, terbinafine, mometasone furoate otic solution Dog Supporting & Related Material Freedom of Information Summary 2015-12-09T05:00:00Z 2015 12     2015-12-09T15:47:16Z   0 0 0900006481d92b7c
FDA-2015-N-0002-0055 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-442 LUTALYSE HighCon Injection Dinoprost Tromethamine Injection Lactating dairy cows, beef cows, beef heifers, and replacement dairy heifers Supporting & Related Material Freedom of Information Summary 2015-12-09T05:00:00Z 2015 12     2015-12-09T15:58:53Z   0 0 0900006481d92bb2
FDA-2015-N-0002-0049 FDA None FDA-2015-N-0002 FINDING OF NO SIGNIFICANT IMPACT AquAdvantage Salmon In support of an approval of a New Animal Drug Application related to AquAdvantage Salmon, which are triploid, hemizygous, all-female Atlantic salmon (Salmo salar) bearing a single copy of the α-form of the opAFP-GHc2 recombinant DNA construct at the α-locus in the EO-1α lineage Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T16:12:31Z   0 0 0900006481d8a198
FDA-2015-N-0002-0047 FDA None FDA-2015-N-0002 AquAdvantage Salmon Environmental Assessment - In support of an approval of a New Animal Drug Application related to AquAdvantage Salmon which are Triploid, Hemizygous, all - female Atlantic salmon (Salmo Salar) bearing a single copy of the a-form of the opAFP-GHc2 recombinant DNA construct at the a-locus in the EO-1a lineage Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T16:04:22Z   0 0 0900006481d89dac
FDA-2015-N-0002-0048 FDA None FDA-2015-N-0002 Freedom of Information Summary NADA 141-454 opAFP-GHc2 rDNA construct in EO-1a lineage Atlantic Salmon (AquAdvantage Salmon) Supporting & Related Material Background Material 2015-12-07T05:00:00Z 2015 12     2015-12-07T16:12:22Z   0 0 0900006481d8a194
FDA-2015-N-0002-0046 FDA None FDA-2015-N-0002 New Animal Drugs in Genetically Engineered Animals; opAFP–GHc2 Recombinant Deoxyribonucleic Acid Construct Rule Final Rule 2015-11-24T05:00:00Z 2015 11 2015-11-24T05:00:00Z   2015-11-24T17:08:38Z 2015-29902 0 0 0900006481d6d2ae
FDA-2015-N-0002-0039 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-438 KAVAULT Avilamycin Type A Medicated Article Swine Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:49:08Z   0 0 0900006481cc5629
FDA-2015-N-0002-0041 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-443 ONSIOR (robenacoxib) injection cats Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:49:20Z   0 0 0900006481cc59d1
FDA-2015-N-0002-0031 FDA None FDA-2015-N-0002 Elanco Animal Health A Division of Eli Lilly and Company 2500 Innovation Way Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:48:06Z   0 0 0900006481cc5621
FDA-2015-N-0002-0032 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA 200-553 Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP Neomycin and polymyxin B sulfates, and bacitracin zinc Ointment Dogs and cats For the treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats when due to organisms susceptible to one Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:48:24Z   0 0 0900006481cc5622
FDA-2015-N-0002-0035 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-583 ACTOGAIN 45 plus RUMENSIN plus TYLOVET 100 plus MGA Ractopamine Hydrochloride plus Monensin USP plus Tylosin Phosphate plus Melengestrol Acetate Type A Medicated Articles for Use in the Manufacture of Type C Medicated Feeds Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:48:44Z   0 0 0900006481cc5625
FDA-2015-N-0002-0037 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-585 ACTOGAIN 45 plus RUMENSIN plus TYLOVET 100 Ractopamine Hydrochloride plus Monensin USP plus Tylosin Phosphate Type A Medicated Articles for Use in the Manufacture of Type B and Type C Medicated Feeds Cattle Fed in Confinement for Slaughter Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:48:56Z   0 0 0900006481cc5627
FDA-2015-N-0002-0045 FDA None FDA-2015-N-0002 Finding of No Significant Impact (FONSI) for KAVAULT (avilamycin) Type A Medicated Article For the reduction in incidence and overall severity of diarrhea in the presence of pathogenic Escherichia coli in Groups of Weaned Pigs Elanco Animal Health Greenfield, IN Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:49:41Z   0 0 0900006481cc59d5
FDA-2015-N-0002-0034 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-582 LONCOR 300 Florfenicol Injectable Solution Beef and Non-lactating Dairy Cattle Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:48:37Z   0 0 0900006481cc5624
FDA-2015-N-0002-0036 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-584 ENGAIN plus TYLOVET 100 Ractopamine Hydrochloride plus Tylosin Phosphate Type A Medicated Articles for Use in the Manufacture of Type B and Type C Medicated Feeds Finishing Swine Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:48:50Z   0 0 0900006481cc5626
FDA-2015-N-0002-0040 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-442 LUTALYSE HighCon Injection Dinoprost tromethamine injection Lactating dairy cows, beef cows, beef heifers, and replacement dairy heifers Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:49:13Z   0 0 0900006481cc59d0
FDA-2015-N-0002-0029 FDA None FDA-2015-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 2015-10-13T04:00:00Z 2015 10 2015-10-13T04:00:00Z   2015-10-13T15:04:00Z 2015-25918 0 0 0900006481cc437c
FDA-2015-N-0002-0043 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-509 TILMOVET 90 Tilmicosin Type A medicated article Beef and Non-Lactating Dairy Cattle Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:49:30Z   0 0 0900006481cc59d3
FDA-2015-N-0002-0030 FDA None FDA-2015-N-0002 New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application; Penicillin G Procaine Rule Withdrawal 2015-10-13T04:00:00Z 2015 10 2015-10-13T04:00:00Z   2015-10-13T15:12:02Z 2015-25919 0 0 0900006481cc492e
FDA-2015-N-0002-0033 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA 200-565 Thiabendazole, Dexamethasone, Neomycin Sulfate Solution Dogs and cats Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:48:30Z   0 0 0900006481cc5623
FDA-2015-N-0002-0038 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-591 NORFENICOL Florfenicol Injectable Solution Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:49:02Z   0 0 0900006481cc5628
FDA-2015-N-0002-0042 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-495 ENROFLOX 100 Enrofloxacin injectable solution Beef and non-lactating dairy cattle Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:49:25Z   0 0 0900006481cc59d2
FDA-2015-N-0002-0044 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-216 QUEST PLUS Gel Moxidectin and praziquantel Oral Gel Horses Supporting & Related Material Background Material 2015-10-13T04:00:00Z 2015 10     2015-10-13T20:49:35Z   0 0 0900006481cc59d4
FDA-2015-N-0002-0026 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA 141-282 ZILMAX plus RUMENSIN plus MGA Zilpaterol Hydrochloride; Monensin, USP; and Melengestrol Acetate Supporting & Related Material Background Material 2015-09-04T04:00:00Z 2015 9     2015-09-04T14:12:04Z   0 0 0900006481c563a8
FDA-2015-N-0002-0020 FDA None FDA-2015-N-0002 New Animal Drugs; Approval of New Animal Drug Applications Rule Correction 2015-09-04T04:00:00Z 2015 9 2015-09-04T04:00:00Z   2015-09-04T14:05:27Z 2015-21905 0 0 0900006481c570fe
FDA-2015-N-0002-0023 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ORIGINAL NEW ANIMAL DRUG APPLICATION NADA 141-417 CORAXIS Moxidectin Solution Dogs Supporting & Related Material Background Material 2015-09-04T04:00:00Z 2015 9     2015-09-04T14:10:17Z   0 0 0900006481c563a5
FDA-2015-N-0002-0024 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA 141-188 MARQUIS (ponazuril) Oral Paste Horses Supporting & Related Material Background Material 2015-09-04T04:00:00Z 2015 9     2015-09-04T14:10:50Z   0 0 0900006481c563a6
FDA-2015-N-0002-0025 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA 141-262 CERENIA Maropitant Citrate Tablets Dogs Supporting & Related Material Background Material 2015-09-04T04:00:00Z 2015 9     2015-09-04T14:11:21Z   0 0 0900006481c563a7
FDA-2015-N-0002-0027 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA 141-284 ZILMAX plus MGA Supporting & Related Material Background Material 2015-09-04T04:00:00Z 2015 9     2015-09-04T14:12:31Z   0 0 0900006481c563a9
FDA-2015-N-0002-0028 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA 141-278 ZILMAX plus RUMENSIN Supporting & Related Material Background Material 2015-09-04T04:00:00Z 2015 9     2015-09-04T14:13:27Z   0 0 0900006481c563aa
FDA-2015-N-0002-0021 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA 200-497 LOXICOM Meloxicam Oral Suspension Dogs Supporting & Related Material Background Material 2015-09-04T04:00:00Z 2015 9     2015-09-04T14:08:59Z   0 0 0900006481c55f0b
FDA-2015-N-0002-0022 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA 200-580 TYLOVET 100 plus SACOX Tylosin phosphate plus Salinomycin sodium Type A Medicated Articles For Use in the Manufacture of Type C Medicated Feeds Broiler Chickens Supporting & Related Material Background Material 2015-09-04T04:00:00Z 2015 9     2015-09-04T14:09:50Z   0 0 0900006481c563a4
FDA-2015-N-0002-0019 FDA None FDA-2015-N-0002 Determination That BIAXIN XL Oral Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2015-08-27T04:00:00Z 2015 8 2015-08-27T04:00:00Z   2015-08-27T14:09:01Z 2015-21236 0 0 0900006481c3d449
FDA-2015-N-0002-0018 FDA None FDA-2015-N-0002 Determination That ABILIFY (Aripiprazole) Solution Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2015-06-23T04:00:00Z 2015 6 2015-06-23T04:00:00Z   2015-06-23T14:11:08Z 2015-15327 0 0 0900006481b4f384
FDA-2015-N-0002-0011 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-557 Tiletamine-Zolazepam tiletamine HCl and zolazepam HCl Injectable solution Dogs and cats Supporting & Related Material Background Material 2015-06-16T04:00:00Z 2015 6     2015-06-16T20:07:05Z   0 0 0900006481b3e437
FDA-2015-N-0002-0016 FDA None FDA-2015-N-0002 FERTAGYL (gonadorelin) Sterile Solution Supporting & Related Material Background Material 2015-06-16T04:00:00Z 2015 6     2015-06-16T20:08:05Z   0 0 0900006481b3e435
FDA-2015-N-0002-0010 FDA None FDA-2015-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Rule Final Rule 2015-06-16T04:00:00Z 2015 6 2015-06-16T04:00:00Z   2015-06-16T13:51:36Z 2015-14734 0 0 0900006481b3c152
FDA-2015-N-0002-0014 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA 141-238 SPECTRAMAST LC Sterile Suspension Ceftiofur Intramammary Suspension Cattle (lactating dairy) Supporting & Related Material Background Material 2015-06-16T04:00:00Z 2015 6     2015-06-16T20:07:28Z   0 0 0900006481b3e43a
FDA-2015-N-0002-0013 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA 200-579 Altrenogest Solution Altrenogest Oral Solution Swine Supporting & Related Material Background Material 2015-06-16T04:00:00Z 2015 6     2015-06-16T20:07:22Z   0 0 0900006481b3e439
FDA-2015-N-0002-0012 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA 200-578 Carprofen Flavored Tablets Carprofen Flavored Tablets Dogs Supporting & Related Material Background Material 2015-06-16T04:00:00Z 2015 6     2015-06-16T20:07:15Z   0 0 0900006481b3e438
FDA-2015-N-0002-0017 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-134 FERTAGYL Gonadorelin Sterile solution Lactating dairy cows Supporting & Related Material Background Material 2015-06-16T04:00:00Z 2015 6     2015-06-16T20:08:20Z   0 0 0900006481b3e436
FDA-2015-N-0002-0015 FDA None FDA-2015-N-0002 Finding of No Significant Impact (FONSI) for FERTAGYL (gonadorelin acetate) For use with ESTRUMATE (cloprostenol injection) to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in Lactating Dairy Cows Supporting & Related Material Background Material 2015-06-16T04:00:00Z 2015 6     2015-06-16T20:07:39Z   0 0 0900006481b3e43b
FDA-2015-N-0002-0009 FDA None FDA-2015-N-0002 Withdrawal of Approval of New Animal Drug Application; Chlortetracycline Notice Withdrawal 2015-06-04T04:00:00Z 2015 6 2015-06-04T04:00:00Z   2015-06-04T15:37:26Z 2015-13633 0 0 0900006481b1a331
FDA-2015-N-0002-0003 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY NADA 141-435 ADVANTUS Imidacloprid Chewable Tablet Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address Supporting & Related Material Background Material 2015-04-08T04:00:00Z 2015 4     2015-04-08T14:45:09Z   0 0 0900006481a94545
FDA-2015-N-0002-0004 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY - NADA 141-418 BETAVET Betamethasone sodium phosphate and betamethasone acetate Injectable Suspension Horses re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address Supporting & Related Material Background Material 2015-04-08T04:00:00Z 2015 4     2015-04-08T14:50:07Z   0 0 0900006481a94011
FDA-2015-N-0002-0008 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY - NADA 141-406 NEXGARD Afoxolaner Chewable Tablet Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address Supporting & Related Material Background Material 2015-04-08T04:00:00Z 2015 4     2015-04-08T14:50:57Z   0 0 0900006481a94552
FDA-2015-N-0002-0006 FDA None FDA-2015-N-0002 Freedom of Information Summary ANADA 200-576 Gentamicin Sulfate Ophthalmic Solution (gentamicin sulfate) Ophthalmic Solution Dogs and cats re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address Supporting & Related Material Background Material 2015-04-08T04:00:00Z 2015 4     2015-04-08T14:50:35Z   0 0 0900006481a9400c
FDA-2015-N-0002-0007 FDA None FDA-2015-N-0002 FREEDOM OF INFORMATION SUMMARY - NADA 141-280 ZILMAX (zilpaterol hydrochloride) plus RUMENSIN (monensin) plus TYLAN (tylosin phosphate) plus MGA (melengestrol acetate) Type A medicated articles re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address Supporting & Related Material Background Material 2015-04-08T04:00:00Z 2015 4     2015-04-08T14:50:45Z   0 0 0900006481a94551
FDA-2015-N-0002-0002 FDA None FDA-2015-N-0002 Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Fomepizole Rule Withdrawal 2015-04-08T04:00:00Z 2015 4 2015-04-08T04:00:00Z   2015-04-08T14:01:00Z 2015-08024 0 0 0900006481a9424e
FDA-2015-N-0002-0001 FDA None FDA-2015-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address Rule Final Rule 2015-04-08T04:00:00Z 2015 4 2015-04-08T04:00:00Z   2015-04-08T13:56:23Z 2015-08025 0 0 0900006481a9424b
FDA-2015-N-0002-0005 FDA None FDA-2015-N-0002 Freedom of Information Summary - ANADA 200-527 Enrofloxacin Antibacterial Injectable Solution re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address Supporting & Related Material Background Material 2015-04-08T04:00:00Z 2015 4     2015-04-08T14:50:22Z   0 0 0900006481a93fcb

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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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