{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) has determined that BUPRENEX (buprenorphine hydrochloride) Injection, 0.3 milligram (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product 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/2023/11/22/2023-25857.html","cfr_references":[],"citation":"88 FR 81419","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2023-P-4223"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-11-22","updated_at":"2023-11-22T11:58:25.900-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-P-4223-0003","allow_late_comments":null,"id":"FDA-2023-P-4223-0003","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-P-4223","title":"Requests that the FDA determine whether the Reference Listed Drug “RLD”, BUPRENEX Buprenorphine Hydrochloride Injection, 0.3 mg/mL, approved under New Drug Application NDA 018401, held by INDIVIOR INC, has been voluntarily withdrawn for reasons of safety or effectiveness."}],"document_number":"2023-25857","effective_on":null,"end_page":81419,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/11/22/2023-25857.xml","html_url":"https://www.federalregister.gov/documents/2023/11/22/2023-25857/determination-that-buprenex-buprenorphine-hydrochloride-injection-03-milligrammilliliter-was-not","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-25857?publication_date=2023-11-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-11-22/2023-25857/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":341,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-22/pdf/2023-25857.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-25857.pdf?1700574434","publication_date":"2023-11-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/11/22/2023-25857.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-2023-P-4223","supporting_documents_count":0,"docket_id":"FDA-2023-P-4223","document_id":"FDA-2023-P-4223-0003","regulation_id_number":null,"title":"Requests that the FDA determine whether the Reference Listed Drug “RLD”, BUPRENEX Buprenorphine Hydrochloride Injection, 0.3 mg/mL, approved under New Drug Application NDA 018401, held by INDIVIOR INC, has been voluntarily withdrawn for reasons of safety or effectiveness.","checked_regulationsdotgov_at":"2023-11-23T16:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":81419,"subtype":null,"title":"Determination That BUPRENEX (Buprenorphine Hydrochloride) Injection, 0.3 Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Buprenex (Buprenorphine Hydrochloride) Injection, 0.3 Milligram/Milliliter","toc_subject":"Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness:\n","topics":[],"type":"Notice","volume":88}