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85 rows where docket_id = "FDA-2014-N-0002" sorted by posted_date descending

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posted_year 3

  • 2014 66
  • 2015 18
  • 2016 1

document_type 2

  • Supporting & Related Material 61
  • Rule 24

agency_id 1

  • FDA 85
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0002-0085 FDA None FDA-2014-N-0002 New Animal Drugs: Change of Sponsor Rule Final Rule 2016-07-26T04:00:00Z 2016 7 2016-07-26T04:00:00Z   2016-07-26T14:45:37Z 2016-17501 0 0 09000064821222dc
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
FDA-2014-N-0002-0065 FDA None FDA-2014-N-0002 Oral Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Oxytetracycline Rule Withdrawal 2014-12-15T05:00:00Z 2014 12 2014-12-15T05:00:00Z   2015-03-23T19:19:16Z 2014-29248 0 0 0900006481976880
FDA-2014-N-0002-0066 FDA None FDA-2014-N-0002 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications Rule Approval 2014-12-15T05:00:00Z 2014 12 2014-12-15T05:00:00Z   2014-12-16T17:01:04Z 2014-29249 0 0 09000064819768af
FDA-2014-N-0002-0059 FDA None FDA-2014-N-0002 Environmental Assessment for Synovex® Choice Implants for Feedlot Beef Steers and Heifers re New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor Supporting & Related Material Background Material 2014-10-28T04:00:00Z 2014 10     2014-10-28T17:14:45Z   0 0 0900006481901c30
FDA-2014-N-0002-0064 FDA None FDA-2014-N-0002 Finding of No Significant Impact (FONSI) in support of a supplemental New Animal Drug Application for SYNOVEX CHOICE (estradiol benzoate and trenbolone acetate implant) re New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor Supporting & Related Material Background Material 2014-10-28T04:00:00Z 2014 10     2014-10-28T17:15:36Z   0 0 0900006481901c35
FDA-2014-N-0002-0057 FDA None FDA-2014-N-0002 New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor Rule Final Rule 2014-10-28T04:00:00Z 2014 10 2014-10-28T04:00:00Z   2014-10-28T15:22:07Z 2014-25588 0 0 09000064819017a0
FDA-2014-N-0002-0060 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 141-043 SYNOVEX CHOICE Trenbolone and estradiol implant Subcutaneous implant Heifers fed in confinement for slaughter re New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2014-10-28T04:00:00Z 2014 10     2014-10-28T17:14:56Z   0 0 0900006481901c31
FDA-2014-N-0002-0063 FDA None FDA-2014-N-0002 Finding of No Significant Impact (FONSI) in support of a New Animal Drug Application for SYNOVEX ONE FEEDLOT (estradiol benzoate and trenbolone acetate extended release implant) for increased rate of weight gain and improved feed efficiency in steers and heifers fed in confinement for slaughter for a period of up to 200 days AND SYNOVEX ONE GRASS re New Animal Drugs; Alfaxalone; Dinoprost; Supporting & Related Material Background Material 2014-10-28T04:00:00Z 2014 10     2014-10-28T17:15:28Z   0 0 0900006481901c34
FDA-2014-N-0002-0058 FDA None FDA-2014-N-0002 Environmental Assessment for Synovex® ONE (Estradiol Benzoate and Trenbolone Acetate Extended Release Implant) Feedlot and Grass for Beef Steers and Heifers re New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor Supporting & Related Material Background Material 2014-10-28T04:00:00Z 2014 10     2014-10-28T17:14:38Z   0 0 0900006481901c2f
FDA-2014-N-0002-0061 FDA None FDA-2014-N-0002 Freedom of Information Summary - SYNOVEX ONE FEEDLOT (trenbolone and estradiol extended release implant). SYNOVEX ONE GRASS (trenbolone and estradiol extended release implant) re New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2014-10-28T04:00:00Z 2014 10     2014-10-28T17:15:03Z   0 0 0900006481901c32
FDA-2014-N-0002-0062 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 140-833 IVOMEC Plus Injection for Cattle ivermectin and clorsulon injection re New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor Supporting & Related Material Freedom of Information Summary 2014-10-28T04:00:00Z 2014 10     2014-10-28T17:15:11Z   0 0 0900006481901c33
FDA-2014-N-0002-0052 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 141-431 FOLLTROPIN Porcine pituitary-derived follicle stimulating hormone for injection Solution for Injection Cattle/beef and dairy heifers and cows Supporting & Related Material Background Material 2014-09-15T04:00:00Z 2014 9     2014-09-15T20:37:32Z   0 0 0900006481872ab3
FDA-2014-N-0002-0049 FDA None FDA-2014-N-0002 Freedom of Information Summary ANADA 200-567 OPTAFLEXX 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 Cattle (heifers) fed in confinement for slaughter Supporting & Related Material Background Material 2014-09-15T04:00:00Z 2014 9     2014-09-15T20:37:16Z   0 0 0900006481872ab0
FDA-2014-N-0002-0053 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 141-434 SIMBADOL Buprenorphine injection Injectable Cats Supporting & Related Material Background Material 2014-09-15T04:00:00Z 2014 9     2014-09-15T20:37:37Z   0 0 0900006481872ad9
FDA-2014-N-0002-0045 FDA None FDA-2014-N-0002 Environmental Assessment for the Use of Tylosin Tartrate for Control of Necrotic Enteritis in Broiler Chickens Supporting & Related Material Background Material 2014-09-15T04:00:00Z 2014 9     2014-09-15T20:36:51Z   0 0 0900006481872aac
FDA-2014-N-0002-0046 FDA None FDA-2014-N-0002 Freedom of Information Summary ANADA 200-520 CARPRIEVE Injection carprofen Injectable Solution Dogs Supporting & Related Material Background Material 2014-09-15T04:00:00Z 2014 9     2014-09-15T20:36:57Z   0 0 0900006481872aad
FDA-2014-N-0002-0054 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 013-076 TYLAN Soluble Tylosin Tartrate Water Soluble Powder Broiler Chickens Supporting & Related Material Background Material 2014-09-15T04:00:00Z 2014 9     2014-09-15T20:37:46Z   0 0 0900006481872ada
FDA-2014-N-0002-0051 FDA None FDA-2014-N-0002 Freedom of Information Summary ANADA 200-570 TYLOVET 100 plus BIO-COX 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 2014-09-15T04:00:00Z 2014 9     2014-09-15T20:37:27Z   0 0 0900006481872ab2
FDA-2014-N-0002-0055 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 141-207 ADVOCIN Sterile Injectable Solution Danofloxacin Injection Beef Cattle Supporting & Related Material Background Material 2014-09-15T04:00:00Z 2014 9     2014-09-15T20:37:52Z   0 0 0900006481872adb
FDA-2014-N-0002-0048 FDA None FDA-2014-N-0002 Freedom of Information Summary ANADA 200-566 OPTAFLEXX 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 2014-09-15T04:00:00Z 2014 9     2014-09-15T20:37:09Z   0 0 0900006481872aaf
FDA-2014-N-0002-0050 FDA None FDA-2014-N-0002 Freedom of Information Summary ANADA 200-569 TYLAN 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 2014-09-15T04:00:00Z 2014 9     2014-09-15T20:37:21Z   0 0 0900006481872ab1
FDA-2014-N-0002-0056 FDA None FDA-2014-N-0002 Finding of No Significant Impact (FONSI) for TYLAN Soluble (Tylosin tartrate) in Broiler Chickens Supporting & Related Material Background Material 2014-09-15T04:00:00Z 2014 9     2014-09-15T20:37:58Z   0 0 0900006481872adc
FDA-2014-N-0002-0047 FDA None FDA-2014-N-0002 Freedom of Information Summary ANADA 200-559 ACTOGAIN 45 plus RUMENSIN ractopamine hydrochloride plus monensin USP Type A Medicated Articles for Use in the Manufacture of Type B and Type C Medicated Feeds Cattle Fed in Confinement for Slaughter during the last 28 to 42 days on feed Supporting & Related Material Background Material 2014-09-15T04:00:00Z 2014 9     2014-09-15T20:37:03Z   0 0 0900006481872aae
FDA-2014-N-0002-0044 FDA None FDA-2014-N-0002 New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin Rule Final Rule 2014-09-08T04:00:00Z 2014 9 2014-09-08T04:00:00Z   2014-09-08T16:53:36Z 2014-20325 0 0 09000064818632fd
FDA-2014-N-0002-0041 FDA None FDA-2014-N-0002 Freedom of Information Summary LUTALYSE (dinoprost injection) Injection re New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin Supporting & Related Material Freedom of Information Summary 2014-07-31T04:00:00Z 2014 7     2014-07-31T14:49:27Z   0 0 09000064817f1443
FDA-2014-N-0002-0040 FDA None FDA-2014-N-0002 New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin Rule Final Rule 2014-07-31T04:00:00Z 2014 7 2014-07-31T04:00:00Z   2014-07-31T14:23:56Z 2014-17912 0 0 09000064817f160d
FDA-2014-N-0002-0042 FDA None FDA-2014-N-0002 Freedom of Information Summary ACTOGAIN (ractopamine HCl), RUMENSIN (monensin), TYLAN (tylosin phosphate), and MGA (melengestrol acetate) Type B and C medicated feeds re New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin Supporting & Related Material Freedom of Information Summary 2014-07-31T04:00:00Z 2014 7     2014-07-31T14:49:18Z   0 0 09000064817f1442
FDA-2014-N-0002-0043 FDA None FDA-2014-N-0002 Freedom of Information Summary ACTOGAIN (ractopamine HCl), RUMENSIN (monensin), MGA (melengestrol acetate), and Type B and C medicated feeds re New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin Supporting & Related Material Freedom of Information Summary 2014-07-31T04:00:00Z 2014 7     2014-07-31T14:49:10Z   0 0 09000064817ef347
FDA-2014-N-0002-0036 FDA None FDA-2014-N-0002 Freedom of Information ANADA 200-558 ENGAIN 9 and 45 (ractopamine HCl) plus TYLAN 100 (tylosin phosphate) Type B and C medicated feeds re New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address Supporting & Related Material Freedom of Information Summary 2014-07-03T04:00:00Z 2014 7     2014-07-03T17:25:54Z   0 0 090000648178df8d
FDA-2014-N-0002-0037 FDA None FDA-2014-N-0002 Freedom of Information ANADA 200-561 ACTOGAIN 45 (ractopamine HCl), RUMENSIN (monensin), and TYLAN 100 (tylosin phosphate) Type B and C medicated feeds re New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address Supporting & Related Material Freedom of Information Summary 2014-07-03T04:00:00Z 2014 7     2014-07-03T17:30:03Z   0 0 090000648178df8e
FDA-2014-N-0002-0038 FDA None FDA-2014-N-0002 Environmental Assessment of the Effects of Chloramine-T Use in and Discharge by Freshwater Aquaculture re New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address Supporting & Related Material Background Material 2014-07-03T04:00:00Z 2014 7     2014-07-03T18:18:57Z   0 0 0900006481763159
FDA-2014-N-0002-0030 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 141-426 BRAVECTO Fluralaner Chewable Tablets Dogs re New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address Supporting & Related Material Freedom of Information Summary 2014-07-03T04:00:00Z 2014 7     2014-07-03T17:05:24Z   0 0 09000064817631cc
FDA-2014-N-0002-0039 FDA None FDA-2014-N-0002 FINDING OF NO SIGNIFICANT IMPACT for HALAMID AQUA (Chloramine-T Powder for Immersion) re New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address Supporting & Related Material Background Material 2014-07-03T04:00:00Z 2014 7     2014-07-03T18:19:37Z   0 0 0900006481763158
FDA-2014-N-0002-0034 FDA None FDA-2014-N-0002 Freedom of Information Summary ANADA 200-513 ENROFLOX Injection for Dogs 2.27% enrofloxacin Injectable Solution Dogs re New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address Supporting & Related Material Freedom of Information Summary 2014-07-03T04:00:00Z 2014 7     2014-07-03T17:11:48Z   0 0 090000648178df8b
FDA-2014-N-0002-0031 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 141-427 OSPHOS Clodronate injection Horse re New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address Supporting & Related Material Freedom of Information Summary 2014-07-03T04:00:00Z 2014 7     2014-07-03T17:05:32Z   0 0 09000064817631cd
FDA-2014-N-0002-0032 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 141-327 LONGRANGE (eprinomectin) Extended Release Injectable Parasiticide Cattle on Pasture re New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address Supporting & Related Material Freedom of Information Summary 2014-07-03T04:00:00Z 2014 7     2014-07-03T17:06:01Z   0 0 09000064817631ce
FDA-2014-N-0002-0035 FDA None FDA-2014-N-0002 Freedom of Information Summary ANADA 200-530 TYLOVET 100 (tylosin phosphate) plus PAYLEAN (ractopamine HCl) Type B and C medicated feeds. re New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address Supporting & Related Material Freedom of Information Summary 2014-07-03T04:00:00Z 2014 7     2014-07-03T17:18:01Z   0 0 090000648178df8c
FDA-2014-N-0002-0028 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 141-421 DUOCARE Ivermectin 1.87% / praziquantel 23.38% Paste Horses re New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address Supporting & Related Material Freedom of Information Summary 2014-07-03T04:00:00Z 2014 7     2014-07-03T17:04:52Z   0 0 09000064817631ca
FDA-2014-N-0002-0029 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 141-423 HALAMID Aqua Chloramine-T Powder for immersion Freshwater-reared salmonids, walleye, and freshwater-reared warmwater finfish re New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address Supporting & Related Material Freedom of Information Summary 2014-07-03T04:00:00Z 2014 7     2014-07-03T17:05:12Z   0 0 09000064817631cb
FDA-2014-N-0002-0033 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 141-406 NEXGARD Afoxolaner Chewable Tablet Dogs re New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address Supporting & Related Material Freedom of Information Summary 2014-07-03T04:00:00Z 2014 7     2014-07-03T17:06:20Z   0 0 09000064817631cf
FDA-2014-N-0002-0025 FDA None FDA-2014-N-0002 New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline; Procaine Penicillin; and Sulfamethazine Rule Final Rule 2014-07-02T04:00:00Z 2014 7 2014-07-02T04:00:00Z   2014-07-02T14:32:37Z 2014-15274 0 0 09000064817870be
FDA-2014-N-0002-0026 FDA None FDA-2014-N-0002 Withdrawal of Approval of Part of a New Animal Drug Application; Procaine Penicillin Rule Withdrawal 2014-07-02T04:00:00Z 2014 7 2014-07-02T04:00:00Z   2015-03-23T18:12:15Z 2014-15273 0 0 0900006481786fc6
FDA-2014-N-0002-0027 FDA None FDA-2014-N-0002 New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor’s Address Rule Final Rule 2014-07-02T04:00:00Z 2014 7 2014-07-02T04:00:00Z   2014-07-02T15:34:44Z 2014-15276 0 0 0900006481787238
FDA-2014-N-0002-0024 FDA None FDA-2014-N-0002 Oral Dosage Form New Animal Drugs; Change of Sponsor Rule Final Rule 2014-05-20T04:00:00Z 2014 5 2014-05-20T04:00:00Z   2014-05-20T14:44:54Z 2014-10415 0 0 09000064817056d1
FDA-2014-N-0002-0023 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-468 GENTAMED-P for Poultry Injection Chickens and Turkeys Supporting & Related Material Freedom of Information Summary 2014-04-16T04:00:00Z 2014 4     2014-04-16T12:22:29Z   0 0 09000064816b59af
FDA-2014-N-0002-0022 FDA None FDA-2014-N-0002 FREEDOM OF INFORMATION SUMMARY ANADA 200-529 XYLAMED xylazine Injection Supporting & Related Material Freedom of Information Summary 2014-04-16T04:00:00Z 2014 4     2014-04-16T12:20:02Z   0 0 09000064816b5986
FDA-2014-N-0002-0021 FDA None FDA-2014-N-0002 New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine Rule Final Rule 2014-04-15T04:00:00Z 2014 4 2014-04-15T04:00:00Z   2014-04-15T15:35:02Z 2014-08445 0 0 09000064816b3fde
FDA-2014-N-0002-0019 FDA None FDA-2014-N-0002 New Animal Drugs for Use in Animal Feeds; Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin Rule Final Rule 2014-04-10T04:00:00Z 2014 4 2014-04-10T04:00:00Z   2015-03-23T19:18:47Z 2014-08011 0 0 09000064816ad8a9
FDA-2014-N-0002-0020 FDA None FDA-2014-N-0002 Withdrawal of Approval of New Animal Drug Applications; Bambermycins; Hygromycin B; Lincomycin; Pyrantel; Tylosin; Tylosin and Sulfamethazine; Virginiamycin Rule Withdrawal 2014-04-10T04:00:00Z 2014 4 2014-04-10T04:00:00Z   2015-03-23T19:19:01Z 2014-08010 0 0 09000064816ad857
FDA-2014-N-0002-0018 FDA None FDA-2014-N-0002 Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug; Correction Rule Withdrawal 2014-04-07T04:00:00Z 2014 4 2014-04-07T04:00:00Z   2015-03-23T19:18:32Z 2014-07702 0 0 09000064816a301d
FDA-2014-N-0002-0017 FDA None FDA-2014-N-0002 Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug; Correction Rule Correction 2014-03-31T04:00:00Z 2014 3 2014-03-31T04:00:00Z   2014-03-31T14:56:48Z 2014-06994 0 0 0900006481691487
FDA-2014-N-0002-0016 FDA None FDA-2014-N-0002 Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor Rule Final Rule 2014-03-25T04:00:00Z 2014 3 2014-03-25T04:00:00Z   2014-03-25T13:46:05Z 2014-06131 0 0 090000648167c94b
FDA-2014-N-0002-0015 FDA None FDA-2014-N-0002 Withdrawal of Approval of New Animal Drug Applications; Chlortetracycline; Sulfathiazole; Penicillin Rule Withdrawal 2014-03-20T04:00:00Z 2014 3 2014-03-20T04:00:00Z   2015-03-23T19:18:14Z 2014-05883 0 0 0900006481671842
FDA-2014-N-0002-0014 FDA None FDA-2014-N-0002 Zoetis Inc., Withdrawal of Approval of New Animal Drug Applications; Chlortetracycline; Sulfathiazole; Penicillin Rule Final Rule 2014-03-20T04:00:00Z 2014 3 2014-03-20T04:00:00Z   2014-03-20T14:12:00Z 2014-05882 0 0 09000064816718df
FDA-2014-N-0002-0009 FDA None FDA-2014-N-0002 Freedom of Information Summary ANADA 200-341 SPARMECTIN-E Liquid for Horses Supporting & Related Material Freedom of Information Summary 2014-03-19T04:00:00Z 2014 3     2014-03-19T14:58:46Z   0 0 090000648166f588
FDA-2014-N-0002-0010 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 140-200 EAZI-BREED CIDR Cattle Insert Progesterone intravaginal insert Anestrous Lactating Dairy Cows Supporting & Related Material Freedom of Information Summary 2014-03-19T04:00:00Z 2014 3     2014-03-19T15:05:38Z   0 0 090000648166f589
FDA-2014-N-0002-0011 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 141-320 ONSIOR tablets Robenacoxib Cats Supporting & Related Material Freedom of Information Summary 2014-03-19T04:00:00Z 2014 3     2014-03-19T15:08:48Z   0 0 090000648166f58a
FDA-2014-N-0002-0012 FDA None FDA-2014-N-0002 Environmental Assessment for Use of the EAZI-BREED™ CIDR Cattle Insert for Induction of Estrous Cycles in Anestrous Lactating Dairy Cows Supporting & Related Material Supplement 2014-03-19T04:00:00Z 2014 3     2014-03-19T15:21:58Z   0 0 090000648166f58b
FDA-2014-N-0002-0006 FDA None FDA-2014-N-0002 Freedom of Information Summary ANADA 200-523 SULFAMED Injection 40 % Cattle Supporting & Related Material Freedom of Information Summary 2014-03-19T04:00:00Z 2014 3     2014-03-19T14:53:50Z   0 0 090000648166f03c
FDA-2014-N-0002-0007 FDA None FDA-2014-N-0002 Freedom of Information Summary ANADA 200-564 Ivermectin Paste 1.87% Paste Horses Supporting & Related Material Freedom of Information Summary 2014-03-19T04:00:00Z 2014 3     2014-03-19T14:46:44Z   0 0 090000648166f586
FDA-2014-N-0002-0008 FDA None FDA-2014-N-0002 Freedom of Information Summary NADA 141-419 COYDEN 25 AND FLAVOMYCIN Broiler Chickens Supporting & Related Material Freedom of Information Summary 2014-03-19T04:00:00Z 2014 3     2014-03-19T14:52:54Z   0 0 090000648166f587
FDA-2014-N-0002-0013 FDA None FDA-2014-N-0002 Finding of No Significant Impact (FONSI) for EAZI-BREED (progesterone) CIDR Cattle Insert in Dairy Cows Supporting & Related Material Supplement 2014-03-19T04:00:00Z 2014 3     2014-03-19T15:26:01Z   0 0 090000648166f58c
FDA-2014-N-0002-0005 FDA None FDA-2014-N-0002 New Animal Drugs; Change of Sponsor Rule Final Rule 2014-03-11T04:00:00Z 2014 3 2014-03-11T04:00:00Z   2014-03-11T14:44:15Z 2014-04937 0 0 090000648165dc9a
FDA-2014-N-0002-0004 FDA None FDA-2014-N-0002 Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug Rule Withdrawal 2014-02-27T05:00:00Z 2014 2 2014-02-27T05:00:00Z   2015-03-23T19:17:47Z 2014-02616 0 0 09000064815d82c7
FDA-2014-N-0002-0002 FDA None FDA-2014-N-0002 New Animal Drugs; Change of Sponsor Rule Final Rule 2014-02-27T05:00:00Z 2014 2 2014-02-27T05:00:00Z   2015-03-23T19:17:10Z 2014-01958 0 0 09000064815d85cf
FDA-2014-N-0002-0001 FDA None FDA-2014-N-0002 New Animal Drugs; Bambermycins; Clopidol; Ivermectin; Penicillin G Procaine and Dihydrostreptomycin Sulfate; Progesterone; Robenicoxib; Sulfadimethoxine; Change of Sponsor; Change of Sponsor’s Address Rule Final Rule 2014-02-27T05:00:00Z 2014 2 2014-02-27T05:00:00Z   2015-03-23T19:16:55Z 2014-01959 0 0 09000064815d861b
FDA-2014-N-0002-0003 FDA None FDA-2014-N-0002 Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug Rule Final Rule 2014-02-27T05:00:00Z 2014 2 2014-02-27T05:00:00Z   2015-03-23T19:17:31Z 2014-02617 0 0 09000064815d82c8

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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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