{"abstract":"The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three abbreviated new drug applications (ANDAs) for propoxyphene drug products from multiple sources and is announcing an opportunity for holders of those ANDAs to request a hearing on this proposal.","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/2014/03/10/2014-05062.html","cfr_references":[],"citation":"79 FR 13310","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written requests for a hearing by April 9, 2014; submit data and information in support of the hearing request by May 9, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-0199"],"dockets":[],"document_number":"2014-05062","effective_on":null,"end_page":13311,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/03/10/2014-05062.xml","html_url":"https://www.federalregister.gov/documents/2014/03/10/2014-05062/mk-laboratories-inc-et-al-proposal-to-withdraw-approval-of-three-abbreviated-new-drug-applications","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-05062?publication_date=2014-03-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-03-10/2014-05062/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":403,"last_updated":"2026-09-22 10:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-03-10/pdf/2014-05062.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-05062.pdf?1394200187","publication_date":"2014-03-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/03/10/2014-05062.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-04-12T05:14:39Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":13310,"subtype":null,"title":"MK Laboratories, Inc., et al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications for Propoxyphene Products; Opportunity for a Hearing","toc_doc":"MK Laboratories, Inc., et al.; Propoxyphene Products","toc_subject":"New Drug Applications: Withdrawal Proposals:","topics":[],"type":"Notice","volume":79}