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withdrawn,object_id FDA-2013-N-0002-0057,FDA,FDA-2013-N-0002,Pulmotil AC (aqueous tilmicosin) Environmental Assessment for the Use of Pulmotil AC to Control Swine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