{"abstract":"The Food and Drug Administration (FDA) has determined that disulfiram (Antabuse) 250- and 500-milligram (mg) tablets, formerly marketed by Wyeth Ayerst Pharmaceuticals (Wyeth Ayerst), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) for disulfiram drug products, and it will allow FDA to continue to approve ANDAs for disulfiram 250- and 500-mg tablets.","action":"Notice.","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/2001/09/26/01-24039.html","cfr_references":[],"citation":"66 FR 49193","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. 01P-0245"],"dockets":[],"document_number":"01-24039","effective_on":null,"end_page":49194,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2001/09/26/01-24039.xml","html_url":"https://www.federalregister.gov/documents/2001/09/26/01-24039/determination-that-disulfiram-tablets-250-and-500-milligrams-were-not-withdrawn-from-sale-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/01-24039?publication_date=2001-09-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2001-09-26/01-24039/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":569,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2001-09-26/pdf/01-24039.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2001-09-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2001/09/26/01-24039.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":49193,"subtype":null,"title":"Determination That Disulfiram Tablets, 250 and 500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Disulfiram tablets, 250 and 500 milligrams","toc_subject":"Human drugs:","topics":[],"type":"Notice","volume":66}