{"abstract":"The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two approved new animal drug applications (NADAs) from Alstoe, Ltd., Animal Health, to Sogeval S.A., and a change of sponsor for an NADA from Nexcyon Pharmaceuticals, Inc. to Elanco Animal Health, A Division of Eli Lilly & Co.","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/2013/07/24/2013-17754.html","cfr_references":[{"chapter":null,"citation_url":null,"part":510,"title":21},{"chapter":null,"citation_url":null,"part":522,"title":21},{"chapter":null,"citation_url":null,"part":524,"title":21}],"citation":"78 FR 44432","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective July 24, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0002"],"dockets":[],"document_number":"2013-17754","effective_on":"2013-07-24","end_page":44433,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/07/24/2013-17754.xml","html_url":"https://www.federalregister.gov/documents/2013/07/24/2013-17754/new-animal-drugs-change-of-sponsor-fentanyl-iron-injection","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-17754?publication_date=2013-07-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-07-24/2013-17754/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":243,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-07-24/pdf/2013-17754.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-17754.pdf?1374584072","publication_date":"2013-07-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/07/24/2013-17754.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FREEDOM OF INFORMATION SUMMARY NADA 130-185\nAMPROL 25% and FLAVOMYCIN Amprolium and Bambermycins","document_id":"FDA-2013-N-0002-0055"},{"title":"FREEDOM OF INFORMATION SUMMARY Application Number 141-422\nPACCAL VET-CA1 Paclitaxel for injection Powder for Injection Dog","document_id":"FDA-2013-N-0002-0054"},{"title":"FREEDOM OF INFORMATION SUMMARY  NADA141-420 TILDREN\ntiludronate disodium Powder for injection Horse","document_id":"FDA-2013-N-0002-0053"},{"title":"FREEDOM OF INFORMATION SUMMARY NADA 141-361\nPULMOTIL AC Tilmicosin Phosphate Aqueous Concentrate\nSwine","document_id":"FDA-2013-N-0002-0052"},{"title":"FREEDOM OF INFORMATION SUMMARY NADA 141-246 AQUAFLOR\nFlorfenicol","document_id":"FDA-2013-N-0002-0051"},{"title":"Freedom of Information Summary NADA 141-288 EXCENEL RTU EZ Ceftiofur Hydrochloride","document_id":"FDA-2013-N-0002-0037"},{"title":"Freedom of Information Summary NADA 095-735 RUMENSIN 90 Monensin","document_id":"FDA-2013-N-0002-0036"},{"title":"Freedom of Information Summary NADA 141-406 NEXGARD Afoxolaner Chewable Tablet","document_id":"FDA-2013-N-0002-0035"},{"title":"Freedom of Information Summary ANADA 200-548 ACTOGAIN 45 Ractopamine Hydrochloride Cattle fed in confinement for slaughter","document_id":"FDA-2013-N-0002-0033"},{"title":"Freedom of Information Summary ANADA 200-542 ENGAIN 9 and ENGAIN 5 Ractopamine Hydrochloride Finishing Swine","document_id":"FDA-2013-N-0002-0032"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-0002","supporting_documents_count":26,"docket_id":"FDA-2013-N-0002","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2013-08-13T08:06:02Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":44432,"subtype":null,"title":"New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection","toc_doc":"Fentanyl; Iron Injection, Change of Sponsor","toc_subject":"New Animal Drugs:","topics":["Administrative practice and procedure","Animal drugs","Labeling","Reporting and recordkeeping requirements"],"type":"Rule","volume":78}