{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that ROXICET (oxycodone hydrochloride (HCl) and acetaminophen) tablet, 5 milligrams (mg)/325 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for oxycodone HCl and acetaminophen tablet, 5 mg/ 325 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/2025/08/04/2025-14707.html","cfr_references":[],"citation":"90 FR 36441","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2025-P-0410"],"dockets":[{"supporting_documents":[{"title":"Attachment 1 Orange Book Page","document_id":"FDA-2025-P-0410-0003"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-08-04","updated_at":"2025-08-04T09:55:49.816-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-P-0410-0004","allow_late_comments":false,"id":"FDA-2025-P-0410-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2025-P-0410","title":"Requests that the FDA determine whether the RLD Roxicet (Oxycodone Hydrochloride and Acetaminophen) Tablets, 5 mg/325 mg PANDA #087003 by Hikma Pharmaceuticals USA INC., has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons."}],"document_number":"2025-14707","effective_on":null,"end_page":36442,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/08/04/2025-14707.xml","html_url":"https://www.federalregister.gov/documents/2025/08/04/2025-14707/determination-that-roxicet-oxycodone-hydrochloride-and-acetaminophen-tablet-5-milligrams-and-325","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-14707?publication_date=2025-08-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-08-04/2025-14707/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":449,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-04/pdf/2025-14707.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14707.pdf?1754052312","publication_date":"2025-08-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/08/04/2025-14707.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 1 Orange Book Page","document_id":"FDA-2025-P-0410-0003"}],"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-P-0410","supporting_documents_count":1,"docket_id":"FDA-2025-P-0410","document_id":"FDA-2025-P-0410-0004","regulation_id_number":null,"title":"Requests that the FDA determine whether the RLD Roxicet (Oxycodone Hydrochloride and Acetaminophen) Tablets, 5 mg/325 mg PANDA #087003 by Hikma Pharmaceuticals USA INC., has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons.","checked_regulationsdotgov_at":"2025-08-05T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":36441,"subtype":null,"title":"Determination That ROXICET (Oxycodone Hydrochloride and Acetaminophen) Tablet, 5 Milligrams and 325 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Roxicet (Oxycodone Hydrochloride and Acetaminophen) Tablet, 5 Milligrams and 325 Milligrams","toc_subject":"Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":90}