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withdrawn,object_id FDA-2015-N-0002-0070,FDA,FDA-2015-N-0002,"New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship",Rule,Correction,2016-04-01T04:00:00Z,2016,4,2016-04-01T04:00:00Z,,2016-04-01T14:05:18Z,C1-2016-07135,0,0,0900006481f0947b FDA-2015-N-0002-0069,FDA,FDA-2015-N-0002,"FONSI for sN 141-361, approved December 7, 2015",Supporting & Related Material,Background Material,2016-03-30T04:00:00Z,2016,3,,,2016-03-31T13:15:00Z,,0,0,0900006481ee9519 FDA-2015-N-0002-0067,FDA,FDA-2015-N-0002,"FOI Summary for sN 141-361, approved December 7, 2015",Supporting & Related Material,Background Material,2016-03-30T04:00:00Z,2016,3,,,2016-03-31T13:14:37Z,,0,0,0900006481ee9517 FDA-2015-N-0002-0063,FDA,FDA-2015-N-0002,"EA for oN 141-453, approved December 8, 2015",Supporting & Related Material,Background Material,2016-03-30T04:00:00Z,2016,3,,,2016-03-31T13:13:05Z,,0,0,0900006481ee8c48 FDA-2015-N-0002-0062,FDA,FDA-2015-N-0002,"New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship",Rule,Final Rule,2016-03-30T04:00:00Z,2016,3,2016-03-30T04:00:00Z,,2016-03-30T20:48:32Z,2016-07135,0,0,0900006481eea5dc FDA-2015-N-0002-0066,FDA,FDA-2015-N-0002,"FOI Summary for sN 141-258, approved December 2, 2015",Supporting & Related Material,Background Material,2016-03-30T04:00:00Z,2016,3,,,2016-03-31T13:14:24Z,,0,0,0900006481ee9516 FDA-2015-N-0002-0068,FDA,FDA-2015-N-0002,"FONSI for oN 141-453, approved December 8, 2015",Supporting & Related Material,Background Material,2016-03-30T04:00:00Z,2016,3,,,2016-03-31T13:14:49Z,,0,0,0900006481ee9518 FDA-2015-N-0002-0064,FDA,FDA-2015-N-0002,"EA for sN 141-361, approved December 7, 2015",Supporting & Related Material,Background Material,2016-03-30T04:00:00Z,2016,3,,,2016-03-31T13:13:53Z,,0,0,0900006481ee8c49 FDA-2015-N-0002-0065,FDA,FDA-2015-N-0002,"FOI Summary for oN 141-453, approved December 8, 2015",Supporting & Related Material,Background Material,2016-03-30T04:00:00Z,2016,3,,,2016-03-31T13:14:12Z,,0,0,0900006481ee9515 FDA-2015-N-0002-0060,FDA,FDA-2015-N-0002,Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib,Rule,Final Rule,2016-01-21T05:00:00Z,2016,1,2016-01-21T05:00:00Z,,2016-01-21T16:13:22Z,2016-01100,0,0,0900006481e24805 FDA-2015-N-0002-0061,FDA,FDA-2015-N-0002,Conditional Approval of a New Animal Drug No Longer In Effect: Masitinib Mesylate Tablets,Notice,Notice of Termination,2016-01-21T05:00:00Z,2016,1,2016-01-21T05:00:00Z,,2016-01-21T16:31:41Z,2016-01104,0,0,0900006481e2489d FDA-2015-N-0002-0059,FDA,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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