{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.","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/2025/05/09/2025-08207.html","cfr_references":[],"citation":"90 FR 19721","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-0679"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-05-09","updated_at":"2025-05-09T09:58:11.795-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-0679-0001","allow_late_comments":false,"id":"FDA-2025-N-0679-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-N-0679","title":"Determination That VOSOL (Acetic Acid, Glacial) 2% Otic Solution/Drops; and Other Drug Products Were Not Withdrawn From Sale For Reasons of Safety or Effectiveness"}],"document_number":"2025-08207","effective_on":null,"end_page":19722,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/05/09/2025-08207.xml","html_url":"https://www.federalregister.gov/documents/2025/05/09/2025-08207/determination-that-vosol-acetic-acid-glacial-2-otic-solutiondrops-and-other-drug-products-were-not","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-08207?publication_date=2025-05-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-05-09/2025-08207/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":262,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-09/pdf/2025-08207.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-08207.pdf?1746708328","publication_date":"2025-05-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/05/09/2025-08207.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-0679","supporting_documents_count":0,"docket_id":"FDA-2025-N-0679","document_id":"FDA-2025-N-0679-0001","regulation_id_number":null,"title":"Determination That VOSOL (Acetic Acid, Glacial) 2% Otic Solution/Drops; and Other Drug Products Were Not Withdrawn From Sale For Reasons of Safety or Effectiveness","checked_regulationsdotgov_at":"2025-05-22T18:55:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":19721,"subtype":null,"title":"Determination That VOSOL (Acetic Acid, Glacial) 2% Otic Solution/Drops; and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Vosol (Acetic Acid, Glacial) 2 Percent Otic Solution/Drops; and Other Drug Products","toc_subject":"Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":90}