{"abstract":"The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for a fomepizole injectable solution used as an antidote for ethylene glycol poisoning in dogs. This action is being taken at the sponsor's request because this product is no longer manufactured or marketed.","action":"Notification of withdrawal.","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/2015/04/08/2015-08024.html","cfr_references":[{"chapter":null,"citation_url":null,"part":522,"title":21}],"citation":"80 FR 18777","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Withdrawal of approval is effective April 20, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-0002"],"dockets":[],"document_number":"2015-08024","effective_on":"2015-04-20","end_page":18777,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/04/08/2015-08024.xml","html_url":"https://www.federalregister.gov/documents/2015/04/08/2015-08024/implantation-or-injectable-dosage-form-new-animal-drugs-withdrawal-of-approval-of-new-animal-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-08024?publication_date=2015-04-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-04-08/2015-08024/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":550,"last_updated":"2026-08-24 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-04-08/pdf/2015-08024.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-08024.pdf?1428410752","publication_date":"2015-04-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/04/08/2015-08024.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FONSI for sN 141-361, approved December 7, 2015","document_id":"FDA-2015-N-0002-0069"},{"title":"FONSI for  oN 141-453, approved December 8, 2015","document_id":"FDA-2015-N-0002-0068"},{"title":"FOI Summary for sN 141-361, approved December 7, 2015","document_id":"FDA-2015-N-0002-0067"},{"title":"FOI Summary for sN 141-258, approved December 2, 2015","document_id":"FDA-2015-N-0002-0066"},{"title":"FOI Summary for oN 141-453, approved December 8, 2015","document_id":"FDA-2015-N-0002-0065"},{"title":"EA for sN 141-361, approved December 7, 2015","document_id":"FDA-2015-N-0002-0064"},{"title":"EA for oN 141-453, approved December 8, 2015","document_id":"FDA-2015-N-0002-0063"},{"title":"Finding of No Significant Impact (FONSI) for SAFE-GUARD AQUASOL\n(fenbendazole oral suspension) in\nChickens","document_id":"FDA-2015-N-0002-0056"},{"title":"FREEDOM OF INFORMATION SUMMARY  NADA 141-442 LUTALYSE HighCon Injection Dinoprost Tromethamine Injection Lactating dairy cows, beef cows, beef heifers, and replacement dairy heifers","document_id":"FDA-2015-N-0002-0055"},{"title":"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","document_id":"FDA-2015-N-0002-0054"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-0002","supporting_documents_count":51,"docket_id":"FDA-2015-N-0002","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2015-04-28T06:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":18777,"subtype":null,"title":"Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Fomepizole","toc_doc":"Fomepizole; Implantation or Injectable Dosage Form; Application Approval Withdrawn","toc_subject":"New Animal Drugs:","topics":[],"type":"Rule","volume":80}