{"abstract":"The Food and Drug Administration (FDA) is withdrawing the approval of abbreviated new drug application (ANDA) 062247 for chloramphenicol capsules, 250 milligrams (mg), held by Ivax Pharmaceuticals, Inc. (Ivax). Ivax requested withdrawal of this application and has waived its opportunity for a hearing.","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/2022/07/27/2022-16077.html","cfr_references":[],"citation":"87 FR 45109","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Approval is withdrawn as of July 27, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-0995"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-07-27","updated_at":"2023-02-27T14:14:24.806-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-0995-0001","allow_late_comments":null,"id":"FDA-2022-N-0995-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-N-0995","title":"Ivax Pharmaceuticals, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Chloramphenicol Capsules, 250 Milligrams"}],"document_number":"2022-16077","effective_on":null,"end_page":45110,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/07/27/2022-16077.xml","html_url":"https://www.federalregister.gov/documents/2022/07/27/2022-16077/ivax-pharmaceuticals-inc-withdrawal-of-approval-of-an-abbreviated-new-drug-application-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-16077?publication_date=2022-07-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-07-27/2022-16077/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":259,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-07-27/pdf/2022-16077.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-16077.pdf?1658839523","publication_date":"2022-07-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/07/27/2022-16077.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-N-0995","supporting_documents_count":0,"docket_id":"FDA-2022-N-0995","document_id":"FDA-2022-N-0995-0001","regulation_id_number":null,"title":"Ivax Pharmaceuticals, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Chloramphenicol Capsules, 250 Milligrams","checked_regulationsdotgov_at":"2023-02-27T19:14:23Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45109,"subtype":null,"title":"Ivax Pharmaceuticals, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Chloramphenicol Capsules, 250 Milligrams","toc_doc":"Ivax Pharmaceuticals, Inc., Chloramphenicol Capsules, 250 Milligrams","toc_subject":"Withdrawal of Approval of Drug Application:\n","topics":[],"type":"Notice","volume":87}