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withdrawn,object_id FDA-2014-N-0002-0085,FDA,FDA-2014-N-0002,New Animal Drugs: Change of Sponsor,Rule,Final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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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