{"abstract":"The Food and Drug Administration (FDA or Agency) is withdrawing approval of 27 abbreviated new drug applications (ANDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2018/08/08/2018-16985.html","cfr_references":[],"citation":"83 FR 39102","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Approval is withdrawn as of September 7, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-2485"],"dockets":[],"document_number":"2018-16985","effective_on":null,"end_page":39103,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/08/08/2018-16985.xml","html_url":"https://www.federalregister.gov/documents/2018/08/08/2018-16985/fougera-pharmaceuticals-inc-et-al-withdrawal-of-approval-of-27-abbreviated-new-drug-applications","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-16985?publication_date=2018-08-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-08-08/2018-16985/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":504,"last_updated":"2026-04-03 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-08-08/pdf/2018-16985.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-16985.pdf?1533645936","publication_date":"2018-08-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/08/08/2018-16985.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2018-08-28T10:00:25Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":39102,"subtype":null,"title":"Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications","toc_doc":"Fougera Pharmaceuticals, Inc., et al.","toc_subject":"Abbreviated New Drug Applications; Withdrawals of Approvals:","topics":[],"type":"Notice","volume":83}