{"abstract":"The Food and Drug Administration (FDA or Agency) is withdrawing approval of eight abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2025/03/14/2025-04106.html","cfr_references":[],"citation":"90 FR 12163","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Approval is withdrawn as of April 14, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-0124"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-03-14","updated_at":"2025-03-14T09:56:35.977-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-0124-0001","allow_late_comments":false,"id":"FDA-2025-N-0124-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-N-0124","title":"Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications"}],"document_number":"2025-04106","effective_on":null,"end_page":12163,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/03/14/2025-04106.xml","html_url":"https://www.federalregister.gov/documents/2025/03/14/2025-04106/bausch-and-lomb-incorporated-et-al-withdrawal-of-approval-of-eight-abbreviated-new-drug-applications","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-04106?publication_date=2025-03-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-03-14/2025-04106/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":496,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-03-14/pdf/2025-04106.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-04106.pdf?1741869913","publication_date":"2025-03-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/03/14/2025-04106.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2025-N-0124","supporting_documents_count":0,"docket_id":"FDA-2025-N-0124","document_id":"FDA-2025-N-0124-0001","regulation_id_number":null,"title":"Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications","checked_regulationsdotgov_at":"2025-03-15T12:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":12163,"subtype":null,"title":"Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications","toc_doc":"Bausch and Lomb Inc., et al.","toc_subject":"Withdrawal of Approval of Drug Application","topics":[],"type":"Notice","volume":90}