{"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 July 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.","action":"Final rule.","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/2012/09/10/2012-22194.html","cfr_references":[{"chapter":null,"citation_url":null,"part":520,"title":21},{"chapter":null,"citation_url":null,"part":522,"title":21},{"chapter":null,"citation_url":null,"part":556,"title":21}],"citation":"77 FR 55414","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective September 10, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0002"],"dockets":[],"document_number":"2012-22194","effective_on":"2012-09-10","end_page":55415,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/09/10/2012-22194.xml","html_url":"https://www.federalregister.gov/documents/2012/09/10/2012-22194/new-animal-drugs-enrofloxacin-tylvalosin","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-22194?publication_date=2012-09-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-09-10/2012-22194/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":528,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-09-10/pdf/2012-22194.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-22194.pdf?1347022176","publication_date":"2012-09-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/09/10/2012-22194.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Freedom of Information Summary ANADA 200-543 Cefpodoxime Proxetil","document_id":"FDA-2012-N-0002-0046"},{"title":"Freedom of Information Summary ANADA 200-491,  Loxicom (meloxicam)","document_id":"FDA-2012-N-0002-0045"},{"title":"Freedom of Information Summary ANADA 200-485,  Meloxicam Injection (meloxicam)","document_id":"FDA-2012-N-0002-0044"},{"title":"Freedom of Information Summary NADA 200-496 96% Solution Growing chickens, turkeys and laying hens","document_id":"FDA-2012-N-0002-0042"},{"title":"Freedom of Information Summary NADA 200-534 Melengestrol acetate plus monensin USP plus tylosin phosphate","document_id":"FDA-2012-N-0002-0041"},{"title":"Freedom of Information Summary NADA 141-068 BAYTRIL 100 Injectable Solution","document_id":"FDA-2012-N-0002-0039"},{"title":"Freedom of Information Summary NADA 141-346 OroCAM","document_id":"FDA-2012-N-0002-0038"},{"title":"Freedom of Information Summary NADA 141-344 VERAFLOX Suspension for Cats","document_id":"FDA-2012-N-0002-0037"},{"title":"Freedom of Information Summary ANADA 200-466 SPARMECTIN Plus Clorsulon","document_id":"FDA-2012-N-0002-0036"},{"title":"Freedom of Information Summary NADA 141-342 ALFAXAN","document_id":"FDA-2012-N-0002-0035"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-N-0002","supporting_documents_count":21,"docket_id":"FDA-2012-N-0002","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2012-09-30T06:00:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":55414,"subtype":null,"title":"New Animal Drugs; Enrofloxacin; Tylvalosin","toc_doc":"Enrofloxacin; Tylvalosin","toc_subject":"New Animal Drugs:","topics":["Animal drugs","Foods"],"type":"Rule","volume":77}