{"abstract":"The Food and Drug Administration (FDA or Agency) is withdrawing approval of 29 new drug applications (NDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2018/07/12/2018-14935.html","cfr_references":[],"citation":"83 FR 32305","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Approval is withdrawn as of August 13, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-2180"],"dockets":[],"document_number":"2018-14935","effective_on":null,"end_page":32306,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/07/12/2018-14935.xml","html_url":"https://www.federalregister.gov/documents/2018/07/12/2018-14935/concordia-pharmaceuticals-inc-et-al-withdrawal-of-approval-of-29-new-drug-applications","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-14935?publication_date=2018-07-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-07-12/2018-14935/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":786,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-07-12/pdf/2018-14935.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-14935.pdf?1531313127","publication_date":"2018-07-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/07/12/2018-14935.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2018-08-01T10:00:28Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":32305,"subtype":null,"title":"Concordia Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 29 New Drug Applications","toc_doc":"Concordia Pharmaceuticals, Inc., et al.","toc_subject":"Withdrawal of Approval of 29 New Drug Applications:","topics":[],"type":"Notice","volume":83}