{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that CIPRO (ciprofloxacin hydrochloride (HCl)) tablet, equivalent to (EQ) 100 milligrams (mg) base, was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for ciprofloxacin HCl tablet, EQ 100 mg base.","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/2024/08/08/2024-17650.html","cfr_references":[],"citation":"89 FR 64921","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-3510"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-08-08","updated_at":"2024-09-03T17:17:39.435-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-3510-0001","allow_late_comments":false,"id":"FDA-2024-N-3510-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-3510","title":"Determination That CIPRO (Ciprofloxacin Hydrochloride) Tablet, Equivalent to 100 Milligrams Base, Was Withdrawn From Sale for Reasons of Safety or Effectiveness"}],"document_number":"2024-17650","effective_on":null,"end_page":64923,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/08/08/2024-17650.xml","html_url":"https://www.federalregister.gov/documents/2024/08/08/2024-17650/determination-that-cipro-ciprofloxacin-hydrochloride-tablet-equivalent-to-100-milligrams-base-was","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-17650?publication_date=2024-08-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-08-08/2024-17650/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":3424,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-08/pdf/2024-17650.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-17650.pdf?1723034815","publication_date":"2024-08-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/08/08/2024-17650.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-2024-N-3510","supporting_documents_count":0,"docket_id":"FDA-2024-N-3510","document_id":"FDA-2024-N-3510-0001","regulation_id_number":null,"title":"Determination That CIPRO (Ciprofloxacin Hydrochloride) Tablet, Equivalent to 100 Milligrams Base, Was Withdrawn From Sale for Reasons of Safety or Effectiveness","checked_regulationsdotgov_at":"2024-08-09T15:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":64921,"subtype":null,"title":"Determination That CIPRO (Ciprofloxacin Hydrochloride) Tablet, Equivalent to 100 Milligrams Base, Was Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Cipro (Ciprofloxacin Hydrochloride) Tablet, Equivalent to 100 Milligrams Base","toc_subject":"Drug Products Withdrawn from Sale for Reasons of Safety or Effectiveness:\n","topics":[],"type":"Notice","volume":89}