{"abstract":"The Food and Drug Administration (FDA) has determined that SUBUTEX (buprenorphine hydrochloride (HCl)) Sublingual Tablets, Equivalent (Eq) 2 milligrams (mg) base and Eq 8 mg base, were not withdrawn from sale for reasons of safety or effectiveness.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 SUBUTEX, and it will allow FDA to continue to approve ANDAs that refer to SUBUTEX 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/2015/02/13/2015-03001.html","cfr_references":[],"citation":"80 FR 8088","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2013-P-1055"],"dockets":[],"document_number":"2015-03001","effective_on":null,"end_page":8089,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/02/13/2015-03001.xml","html_url":"https://www.federalregister.gov/documents/2015/02/13/2015-03001/determination-that-subutex-buprenorphine-hydrochloride-sublingual-tablets-equivalent-2-milligrams","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-03001?publication_date=2015-02-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-02-13/2015-03001/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":9824,"last_updated":"2026-04-06 22:15:10 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-02-13/pdf/2015-03001.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-03001.pdf?1423749248","publication_date":"2015-02-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/02/13/2015-03001.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-P-1055","supporting_documents_count":0,"docket_id":"FDA-2013-P-1055","regulation_id_number":null,"title":"Determine That SUBUTEX® (Buprenorphine Hydrochloride) Sublingual Tablets, EQ. 2 mg and 8 mg Base Were not Voluntarily Withdrawn for Safety and Efficacy Reasons","checked_regulationsdotgov_at":"2015-03-05T06:00:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":8088,"subtype":null,"title":"Determination That SUBUTEX (Buprenorphine Hydrochloride) Sublingual Tablets, Equivalent 2 Milligrams Base and Equivalent 8 Milligrams Base, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"SUBUTEX (Buprenorphine Hydrochloride) Sublingual Tablets, Equivalent 2 and 8 Milligrams Base","toc_subject":"Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":80}