{"abstract":"The Food and Drug Administration (FDA) has determined that SUBOXONE (buprenorphine hydrochloride (HCl) and naloxone HCl) sublingual tablets, 2 milligrams (mg)/0.5 mg and 8 mg/2 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 buprenorphine HCl and naloxone HCl sublingual tablets, 2 mg/0.5 mg and 8 mg/2 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/2013/06/06/2013-13446.html","cfr_references":[],"citation":"78 FR 34108","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2012-P-1034"],"dockets":[],"document_number":"2013-13446","effective_on":null,"end_page":34109,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/06/06/2013-13446.xml","html_url":"https://www.federalregister.gov/documents/2013/06/06/2013-13446/determination-that-suboxone-buprenorphine-hydrochloride-and-naloxone-hydrochloride-sublingual","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-13446?publication_date=2013-06-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-06-06/2013-13446/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2370,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-06-06/pdf/2013-13446.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-13446.pdf?1370437229","publication_date":"2013-06-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/06/06/2013-13446.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-2012-P-1034","supporting_documents_count":0,"docket_id":"FDA-2012-P-1034","regulation_id_number":null,"title":"Determine Whether SUBOXONE® (Buprenorphine Hydrochloride and Naloxone hydrochloride) Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg¹ Have Been Voluntarily Withdrawn From Sale - CLOSED","checked_regulationsdotgov_at":"2013-06-26T08:06:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":34108,"subtype":null,"title":"Determination That SUBOXONE (Buprenorphine Hydrochloride and Naloxone Hydrochloride) Sublingual Tablets, 2 Milligrams/0.5 Milligrams and 8 Milligrams/2 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"SUBOXONE (Buprenorphine Hydrochloride and Naloxone Hydrochloride) Sublingual Tablets, 2 Milligrams/0.5 Milligrams and 8 Milligrams/2 Milligrams","toc_subject":"Drugs Not Withdrawn from Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":78}