{"abstract":"The Food and Drug Administration (FDA, Agency, or we) has determined that ANSAID (flurbiprofen) tablets, 50 milligrams (mg) and 100 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for flurbiprofen tablets, 50 mg and 100 mg, if all other legal and regulatory requirements are met.","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/2026/08/14/2026-16666.html","cfr_references":[],"citation":"91 FR 52708","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2026-P-3166"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-08-14","updated_at":"2026-08-14T10:57:12.033-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-P-3166-0003","allow_late_comments":false,"id":"FDA-2026-P-3166-0003","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-P-3166","title":"Requests that the FDA make a determination that the discontinued FLURBIPROFEN Oral Tablet 100 mg and 50 mg, (NDA 018766) from PHARMACIA AND UPJOHN CO was not discontinued or withdrawn due to safety or efficacy reasons"}],"document_number":"2026-16666","effective_on":null,"end_page":52708,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/08/14/2026-16666.xml","html_url":"https://www.federalregister.gov/documents/2026/08/14/2026-16666/determination-that-ansaid-flurbiprofen-tablets-50-milligrams-and-100-milligrams-were-not-withdrawn","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-16666?publication_date=2026-08-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-08-14/2026-16666/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":166,"last_updated":"2026-09-21 14:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-14/pdf/2026-16666.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16666.pdf?1786625121","publication_date":"2026-08-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/08/14/2026-16666.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-2026-P-3166","supporting_documents_count":0,"docket_id":"FDA-2026-P-3166","document_id":"FDA-2026-P-3166-0003","regulation_id_number":null,"title":"Requests that the FDA make a determination that the discontinued FLURBIPROFEN Oral Tablet 100 mg and 50 mg, (NDA 018766) from PHARMACIA AND UPJOHN CO was not discontinued or withdrawn due to safety or efficacy reasons","checked_regulationsdotgov_at":"2026-08-15T18:55:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52708,"subtype":null,"title":"Determination That ANSAID (Flurbiprofen) Tablets, 50 Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"ANSAID (Flurbiprofen) Tablets, 50 Milligrams and 100 Milligrams","toc_subject":"Determination that Drugs Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":91}