{"abstract":"The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of eight NADAs and nine ANADAs, and to make correcting amendments for a drug labeler code.","action":"Final rule; technical amendments.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2015/03/13/2015-05644.html","cfr_references":[{"chapter":null,"citation_url":null,"part":510,"title":21},{"chapter":null,"citation_url":null,"part":520,"title":21},{"chapter":null,"citation_url":null,"part":522,"title":21},{"chapter":null,"citation_url":null,"part":524,"title":21},{"chapter":null,"citation_url":null,"part":556,"title":21},{"chapter":null,"citation_url":null,"part":558,"title":21}],"citation":"80 FR 13226","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective March 13, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-0002"],"dockets":[],"document_number":"2015-05644","effective_on":"2015-03-13","end_page":13232,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/03/13/2015-05644.xml","html_url":"https://www.federalregister.gov/documents/2015/03/13/2015-05644/new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsor","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-05644?publication_date=2015-03-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-03-13/2015-05644/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":886,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-03-13/pdf/2015-05644.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-05644.pdf?1426164325","publication_date":"2015-03-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/03/13/2015-05644.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FREEDOM OF INFORMATION SUMMARY ANADA 200-512 TRIAMULOX\ntiamulin hydrogen fumarate, 12.3% Liquid Concentrate Swine re New Animal Drugs; Approval of New Animal Drug Applications; Change of\nSponsor","document_id":"FDA-2014-N-0002-0084"},{"title":"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","document_id":"FDA-2014-N-0002-0083"},{"title":"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","document_id":"FDA-2014-N-0002-0082"},{"title":"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 Confinemen","document_id":"FDA-2014-N-0002-0081"},{"title":"FREEDOM OF INFORMATION SUMMARY NADA 141-258 ZILMAX\nZilpaterol 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 Dru","document_id":"FDA-2014-N-0002-0080"},{"title":"FREEDOM OF INFORMATION SUMMARY NADA 141-232\nSIMPLICEF Cefpodoxime proxetil Chewable tablets Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor","document_id":"FDA-2014-N-0002-0079"},{"title":"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","document_id":"FDA-2014-N-0002-0078"},{"title":"FREEDOM OF INFORMATION SUMMARY NADA 141-034 GAINPRO\nbambermycins 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 ","document_id":"FDA-2014-N-0002-0077"},{"title":"FREEDOM OF INFORMATION SUMMARY NADA 141-437\nOSURNIA florfenicol, terbinafine, betamethasone acetate Otic gel\nDogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor","document_id":"FDA-2014-N-0002-0076"},{"title":"FREEDOM OF INFORMATION SUMMARY ANADA 200-575\nCarprofen Chewable Tablets Carprofen Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor","document_id":"FDA-2014-N-0002-0075"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-0002","supporting_documents_count":61,"docket_id":"FDA-2014-N-0002","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2015-04-02T06:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":13226,"subtype":null,"title":"New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor","toc_doc":"Application Approvals; Change of Sponsor","toc_subject":"New Animal Drugs:","topics":["Administrative practice and procedure","Animal drugs","Animal feeds","Foods","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":80}