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70 rows where docket_id = "FDA-2015-N-0002" sorted by posted_date descending
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document_type 3
- Supporting & Related Material 51
- Rule 15
- Notice 4
agency_id 1
- FDA 70
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None FDA-2015-N-0002 | New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate | Rule | Final Rule | 2015-12-22T05:00:00Z | 2015 | 12 | 2015-12-22T05:00:00Z | 2015-12-22T14:25:51Z | 2015-32000 | 0 | 0 | 0900006481dc12f6 | |
| FDA-2015-N-0002-0057 | FDA | None FDA-2015-N-0002 | New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of New Animal Drug Applications; Nitarsone | Rule | Withdrawal | 2015-12-18T05:00:00Z | 2015 | 12 | 2015-12-18T05:00:00Z | 2015-12-18T14:31:28Z | 2015-31828 | 0 | 0 | 0900006481db9730 | |
| FDA-2015-N-0002-0058 | FDA | None FDA-2015-N-0002 | New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of New Animal Drug Applications; Nitarsone | Rule | Final Rule | 2015-12-18T05:00:00Z | 2015 | 12 | 2015-12-18T05:00:00Z | 2015-12-18T14:34:22Z | 2015-31827 | 0 | 0 | 0900006481db988a | |
| FDA-2015-N-0002-0050 | FDA | None FDA-2015-N-0002 | New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship | Rule | Final Rule | 2015-12-09T05:00:00Z | 2015 | 12 | 2015-12-09T05:00:00Z | 2015-12-09T15:36:21Z | 2015-31042 | 0 | 0 | 0900006481d9202e | |
| FDA-2015-N-0002-0051 | FDA | None FDA-2015-N-0002 | New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications | Rule | Withdrawal | 2015-12-09T05:00:00Z | 2015 | 12 | 2015-12-09T05:00:00Z | 2015-12-09T15:39:22Z | 2015-31040 | 0 | 0 | 0900006481d92512 | |
| FDA-2015-N-0002-0053 | FDA | None FDA-2015-N-0002 | Environmental Assessment Safe-Guard Aquasol for Chicken (20% Fenbendazole Suspension | Supporting & Related Material | Background Material | 2015-12-09T05:00:00Z | 2015 | 12 | 2015-12-09T15:53:03Z | 0 | 0 | 0900006481d92b7b | |||
| FDA-2015-N-0002-0054 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY NADA 141-449 SAFE-GUARD AquaSol Fenbendazole oral suspension Broiler chickens, replacement chickens intended to become breeding chickens, and breeding chickens | Supporting & Related Material | Freedom of Information Summary | 2015-12-09T05:00:00Z | 2015 | 12 | 2015-12-09T15:55:42Z | 0 | 0 | 0900006481d92b7d | |||
| FDA-2015-N-0002-0056 | FDA | None FDA-2015-N-0002 | Finding of No Significant Impact (FONSI) for SAFE-GUARD AQUASOL (fenbendazole oral suspension) in Chickens | Supporting & Related Material | Background Material | 2015-12-09T05:00:00Z | 2015 | 12 | 2015-12-09T16:03:27Z | 0 | 0 | 0900006481d92bb3 | |||
| FDA-2015-N-0002-0052 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY NADA 141-440 CLARO Florfenicol, terbinafine, mometasone furoate otic solution Dog | Supporting & Related Material | Freedom of Information Summary | 2015-12-09T05:00:00Z | 2015 | 12 | 2015-12-09T15:47:16Z | 0 | 0 | 0900006481d92b7c | |||
| FDA-2015-N-0002-0055 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY NADA 141-442 LUTALYSE HighCon Injection Dinoprost Tromethamine Injection Lactating dairy cows, beef cows, beef heifers, and replacement dairy heifers | Supporting & Related Material | Freedom of Information Summary | 2015-12-09T05:00:00Z | 2015 | 12 | 2015-12-09T15:58:53Z | 0 | 0 | 0900006481d92bb2 | |||
| FDA-2015-N-0002-0049 | FDA | None FDA-2015-N-0002 | FINDING OF NO SIGNIFICANT IMPACT AquAdvantage Salmon In support of an approval of a New Animal Drug Application related to AquAdvantage Salmon, which are triploid, hemizygous, all-female Atlantic salmon (Salmo salar) bearing a single copy of the α-form of the opAFP-GHc2 recombinant DNA construct at the α-locus in the EO-1α lineage | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T16:12:31Z | 0 | 0 | 0900006481d8a198 | |||
| FDA-2015-N-0002-0047 | FDA | None FDA-2015-N-0002 | AquAdvantage Salmon Environmental Assessment - In support of an approval of a New Animal Drug Application related to AquAdvantage Salmon which are Triploid, Hemizygous, all - female Atlantic salmon (Salmo Salar) bearing a single copy of the a-form of the opAFP-GHc2 recombinant DNA construct at the a-locus in the EO-1a lineage | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T16:04:22Z | 0 | 0 | 0900006481d89dac | |||
| FDA-2015-N-0002-0048 | FDA | None FDA-2015-N-0002 | Freedom of Information Summary NADA 141-454 opAFP-GHc2 rDNA construct in EO-1a lineage Atlantic Salmon (AquAdvantage Salmon) | Supporting & Related Material | Background Material | 2015-12-07T05:00:00Z | 2015 | 12 | 2015-12-07T16:12:22Z | 0 | 0 | 0900006481d8a194 | |||
| FDA-2015-N-0002-0046 | FDA | None FDA-2015-N-0002 | New Animal Drugs in Genetically Engineered Animals; opAFP–GHc2 Recombinant Deoxyribonucleic Acid Construct | Rule | Final Rule | 2015-11-24T05:00:00Z | 2015 | 11 | 2015-11-24T05:00:00Z | 2015-11-24T17:08:38Z | 2015-29902 | 0 | 0 | 0900006481d6d2ae | |
| FDA-2015-N-0002-0039 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY NADA 141-438 KAVAULT Avilamycin Type A Medicated Article Swine | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:49:08Z | 0 | 0 | 0900006481cc5629 | |||
| FDA-2015-N-0002-0041 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY NADA 141-443 ONSIOR (robenacoxib) injection cats | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:49:20Z | 0 | 0 | 0900006481cc59d1 | |||
| FDA-2015-N-0002-0031 | FDA | None FDA-2015-N-0002 | Elanco Animal Health A Division of Eli Lilly and Company 2500 Innovation Way | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:48:06Z | 0 | 0 | 0900006481cc5621 | |||
| FDA-2015-N-0002-0032 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA 200-553 Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP Neomycin and polymyxin B sulfates, and bacitracin zinc Ointment Dogs and cats For the treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats when due to organisms susceptible to one | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:48:24Z | 0 | 0 | 0900006481cc5622 | |||
| FDA-2015-N-0002-0035 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ANADA 200-583 ACTOGAIN 45 plus RUMENSIN plus TYLOVET 100 plus MGA Ractopamine Hydrochloride plus Monensin USP plus Tylosin Phosphate plus Melengestrol Acetate Type A Medicated Articles for Use in the Manufacture of Type C Medicated Feeds | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:48:44Z | 0 | 0 | 0900006481cc5625 | |||
| FDA-2015-N-0002-0037 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ANADA 200-585 ACTOGAIN 45 plus RUMENSIN plus TYLOVET 100 Ractopamine Hydrochloride plus Monensin USP plus Tylosin Phosphate Type A Medicated Articles for Use in the Manufacture of Type B and Type C Medicated Feeds Cattle Fed in Confinement for Slaughter | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:48:56Z | 0 | 0 | 0900006481cc5627 | |||
| FDA-2015-N-0002-0045 | FDA | None FDA-2015-N-0002 | Finding of No Significant Impact (FONSI) for KAVAULT (avilamycin) Type A Medicated Article For the reduction in incidence and overall severity of diarrhea in the presence of pathogenic Escherichia coli in Groups of Weaned Pigs Elanco Animal Health Greenfield, IN | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:49:41Z | 0 | 0 | 0900006481cc59d5 | |||
| FDA-2015-N-0002-0034 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ANADA 200-582 LONCOR 300 Florfenicol Injectable Solution Beef and Non-lactating Dairy Cattle | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:48:37Z | 0 | 0 | 0900006481cc5624 | |||
| FDA-2015-N-0002-0036 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ANADA 200-584 ENGAIN plus TYLOVET 100 Ractopamine Hydrochloride plus Tylosin Phosphate Type A Medicated Articles for Use in the Manufacture of Type B and Type C Medicated Feeds Finishing Swine | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:48:50Z | 0 | 0 | 0900006481cc5626 | |||
| FDA-2015-N-0002-0040 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY NADA 141-442 LUTALYSE HighCon Injection Dinoprost tromethamine injection Lactating dairy cows, beef cows, beef heifers, and replacement dairy heifers | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:49:13Z | 0 | 0 | 0900006481cc59d0 | |||
| FDA-2015-N-0002-0029 | FDA | None FDA-2015-N-0002 | New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor’s Address | Rule | Final Rule | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T04:00:00Z | 2015-10-13T15:04:00Z | 2015-25918 | 0 | 0 | 0900006481cc437c | |
| FDA-2015-N-0002-0043 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ANADA 200-509 TILMOVET 90 Tilmicosin Type A medicated article Beef and Non-Lactating Dairy Cattle | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:49:30Z | 0 | 0 | 0900006481cc59d3 | |||
| FDA-2015-N-0002-0030 | FDA | None FDA-2015-N-0002 | New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application; Penicillin G Procaine | Rule | Withdrawal | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T04:00:00Z | 2015-10-13T15:12:02Z | 2015-25919 | 0 | 0 | 0900006481cc492e | |
| FDA-2015-N-0002-0033 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA 200-565 Thiabendazole, Dexamethasone, Neomycin Sulfate Solution Dogs and cats | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:48:30Z | 0 | 0 | 0900006481cc5623 | |||
| FDA-2015-N-0002-0038 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ANADA 200-591 NORFENICOL Florfenicol Injectable Solution | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:49:02Z | 0 | 0 | 0900006481cc5628 | |||
| FDA-2015-N-0002-0042 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ANADA 200-495 ENROFLOX 100 Enrofloxacin injectable solution Beef and non-lactating dairy cattle | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:49:25Z | 0 | 0 | 0900006481cc59d2 | |||
| FDA-2015-N-0002-0044 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY NADA 141-216 QUEST PLUS Gel Moxidectin and praziquantel Oral Gel Horses | Supporting & Related Material | Background Material | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T20:49:35Z | 0 | 0 | 0900006481cc59d4 | |||
| FDA-2015-N-0002-0026 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA 141-282 ZILMAX plus RUMENSIN plus MGA Zilpaterol Hydrochloride; Monensin, USP; and Melengestrol Acetate | Supporting & Related Material | Background Material | 2015-09-04T04:00:00Z | 2015 | 9 | 2015-09-04T14:12:04Z | 0 | 0 | 0900006481c563a8 | |||
| FDA-2015-N-0002-0020 | FDA | None FDA-2015-N-0002 | New Animal Drugs; Approval of New Animal Drug Applications | Rule | Correction | 2015-09-04T04:00:00Z | 2015 | 9 | 2015-09-04T04:00:00Z | 2015-09-04T14:05:27Z | 2015-21905 | 0 | 0 | 0900006481c570fe | |
| FDA-2015-N-0002-0023 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ORIGINAL NEW ANIMAL DRUG APPLICATION NADA 141-417 CORAXIS Moxidectin Solution Dogs | Supporting & Related Material | Background Material | 2015-09-04T04:00:00Z | 2015 | 9 | 2015-09-04T14:10:17Z | 0 | 0 | 0900006481c563a5 | |||
| FDA-2015-N-0002-0024 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA 141-188 MARQUIS (ponazuril) Oral Paste Horses | Supporting & Related Material | Background Material | 2015-09-04T04:00:00Z | 2015 | 9 | 2015-09-04T14:10:50Z | 0 | 0 | 0900006481c563a6 | |||
| FDA-2015-N-0002-0025 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA 141-262 CERENIA Maropitant Citrate Tablets Dogs | Supporting & Related Material | Background Material | 2015-09-04T04:00:00Z | 2015 | 9 | 2015-09-04T14:11:21Z | 0 | 0 | 0900006481c563a7 | |||
| FDA-2015-N-0002-0027 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA 141-284 ZILMAX plus MGA | Supporting & Related Material | Background Material | 2015-09-04T04:00:00Z | 2015 | 9 | 2015-09-04T14:12:31Z | 0 | 0 | 0900006481c563a9 | |||
| FDA-2015-N-0002-0028 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA 141-278 ZILMAX plus RUMENSIN | Supporting & Related Material | Background Material | 2015-09-04T04:00:00Z | 2015 | 9 | 2015-09-04T14:13:27Z | 0 | 0 | 0900006481c563aa | |||
| FDA-2015-N-0002-0021 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA 200-497 LOXICOM Meloxicam Oral Suspension Dogs | Supporting & Related Material | Background Material | 2015-09-04T04:00:00Z | 2015 | 9 | 2015-09-04T14:08:59Z | 0 | 0 | 0900006481c55f0b | |||
| FDA-2015-N-0002-0022 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA 200-580 TYLOVET 100 plus SACOX Tylosin phosphate plus Salinomycin sodium Type A Medicated Articles For Use in the Manufacture of Type C Medicated Feeds Broiler Chickens | Supporting & Related Material | Background Material | 2015-09-04T04:00:00Z | 2015 | 9 | 2015-09-04T14:09:50Z | 0 | 0 | 0900006481c563a4 | |||
| FDA-2015-N-0002-0019 | FDA | None FDA-2015-N-0002 | Determination That BIAXIN XL Oral Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2015-08-27T04:00:00Z | 2015 | 8 | 2015-08-27T04:00:00Z | 2015-08-27T14:09:01Z | 2015-21236 | 0 | 0 | 0900006481c3d449 | |
| FDA-2015-N-0002-0018 | FDA | None FDA-2015-N-0002 | Determination That ABILIFY (Aripiprazole) Solution Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | Determinations | 2015-06-23T04:00:00Z | 2015 | 6 | 2015-06-23T04:00:00Z | 2015-06-23T14:11:08Z | 2015-15327 | 0 | 0 | 0900006481b4f384 | |
| FDA-2015-N-0002-0011 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ANADA 200-557 Tiletamine-Zolazepam tiletamine HCl and zolazepam HCl Injectable solution Dogs and cats | Supporting & Related Material | Background Material | 2015-06-16T04:00:00Z | 2015 | 6 | 2015-06-16T20:07:05Z | 0 | 0 | 0900006481b3e437 | |||
| FDA-2015-N-0002-0016 | FDA | None FDA-2015-N-0002 | FERTAGYL (gonadorelin) Sterile Solution | Supporting & Related Material | Background Material | 2015-06-16T04:00:00Z | 2015 | 6 | 2015-06-16T20:08:05Z | 0 | 0 | 0900006481b3e435 | |||
| FDA-2015-N-0002-0010 | FDA | None FDA-2015-N-0002 | New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor | Rule | Final Rule | 2015-06-16T04:00:00Z | 2015 | 6 | 2015-06-16T04:00:00Z | 2015-06-16T13:51:36Z | 2015-14734 | 0 | 0 | 0900006481b3c152 | |
| FDA-2015-N-0002-0014 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA 141-238 SPECTRAMAST LC Sterile Suspension Ceftiofur Intramammary Suspension Cattle (lactating dairy) | Supporting & Related Material | Background Material | 2015-06-16T04:00:00Z | 2015 | 6 | 2015-06-16T20:07:28Z | 0 | 0 | 0900006481b3e43a | |||
| FDA-2015-N-0002-0013 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA 200-579 Altrenogest Solution Altrenogest Oral Solution Swine | Supporting & Related Material | Background Material | 2015-06-16T04:00:00Z | 2015 | 6 | 2015-06-16T20:07:22Z | 0 | 0 | 0900006481b3e439 | |||
| FDA-2015-N-0002-0012 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA 200-578 Carprofen Flavored Tablets Carprofen Flavored Tablets Dogs | Supporting & Related Material | Background Material | 2015-06-16T04:00:00Z | 2015 | 6 | 2015-06-16T20:07:15Z | 0 | 0 | 0900006481b3e438 | |||
| FDA-2015-N-0002-0017 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY ANADA 200-134 FERTAGYL Gonadorelin Sterile solution Lactating dairy cows | Supporting & Related Material | Background Material | 2015-06-16T04:00:00Z | 2015 | 6 | 2015-06-16T20:08:20Z | 0 | 0 | 0900006481b3e436 | |||
| FDA-2015-N-0002-0015 | FDA | None FDA-2015-N-0002 | Finding of No Significant Impact (FONSI) for FERTAGYL (gonadorelin acetate) For use with ESTRUMATE (cloprostenol injection) to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in Lactating Dairy Cows | Supporting & Related Material | Background Material | 2015-06-16T04:00:00Z | 2015 | 6 | 2015-06-16T20:07:39Z | 0 | 0 | 0900006481b3e43b | |||
| FDA-2015-N-0002-0009 | FDA | None FDA-2015-N-0002 | Withdrawal of Approval of New Animal Drug Application; Chlortetracycline | Notice | Withdrawal | 2015-06-04T04:00:00Z | 2015 | 6 | 2015-06-04T04:00:00Z | 2015-06-04T15:37:26Z | 2015-13633 | 0 | 0 | 0900006481b1a331 | |
| FDA-2015-N-0002-0003 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY NADA 141-435 ADVANTUS Imidacloprid Chewable Tablet Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address | Supporting & Related Material | Background Material | 2015-04-08T04:00:00Z | 2015 | 4 | 2015-04-08T14:45:09Z | 0 | 0 | 0900006481a94545 | |||
| FDA-2015-N-0002-0004 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY - NADA 141-418 BETAVET Betamethasone sodium phosphate and betamethasone acetate Injectable Suspension Horses re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address | Supporting & Related Material | Background Material | 2015-04-08T04:00:00Z | 2015 | 4 | 2015-04-08T14:50:07Z | 0 | 0 | 0900006481a94011 | |||
| FDA-2015-N-0002-0008 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY - NADA 141-406 NEXGARD Afoxolaner Chewable Tablet Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address | Supporting & Related Material | Background Material | 2015-04-08T04:00:00Z | 2015 | 4 | 2015-04-08T14:50:57Z | 0 | 0 | 0900006481a94552 | |||
| FDA-2015-N-0002-0006 | FDA | None FDA-2015-N-0002 | Freedom of Information Summary ANADA 200-576 Gentamicin Sulfate Ophthalmic Solution (gentamicin sulfate) Ophthalmic Solution Dogs and cats re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address | Supporting & Related Material | Background Material | 2015-04-08T04:00:00Z | 2015 | 4 | 2015-04-08T14:50:35Z | 0 | 0 | 0900006481a9400c | |||
| FDA-2015-N-0002-0007 | FDA | None FDA-2015-N-0002 | FREEDOM OF INFORMATION SUMMARY - NADA 141-280 ZILMAX (zilpaterol hydrochloride) plus RUMENSIN (monensin) plus TYLAN (tylosin phosphate) plus MGA (melengestrol acetate) Type A medicated articles re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address | Supporting & Related Material | Background Material | 2015-04-08T04:00:00Z | 2015 | 4 | 2015-04-08T14:50:45Z | 0 | 0 | 0900006481a94551 | |||
| FDA-2015-N-0002-0002 | FDA | None FDA-2015-N-0002 | Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Fomepizole | Rule | Withdrawal | 2015-04-08T04:00:00Z | 2015 | 4 | 2015-04-08T04:00:00Z | 2015-04-08T14:01:00Z | 2015-08024 | 0 | 0 | 0900006481a9424e | |
| FDA-2015-N-0002-0001 | FDA | None FDA-2015-N-0002 | New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address | Rule | Final Rule | 2015-04-08T04:00:00Z | 2015 | 4 | 2015-04-08T04:00:00Z | 2015-04-08T13:56:23Z | 2015-08025 | 0 | 0 | 0900006481a9424b | |
| FDA-2015-N-0002-0005 | FDA | None FDA-2015-N-0002 | Freedom of Information Summary - ANADA 200-527 Enrofloxacin Antibacterial Injectable Solution re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor’s Name; Change of Sponsor’s Address | Supporting & Related Material | Background Material | 2015-04-08T04:00:00Z | 2015 | 4 | 2015-04-08T14:50:22Z | 0 | 0 | 0900006481a93fcb |
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