{"abstract":"The Food and Drug Administration (FDA) has determined that CHLOROMYCETIN (chloramphenicol) Capsules, 250 milligrams (mg), were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for chloramphenicol capsules, 250 mg.","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/2012/07/13/2012-17091.html","cfr_references":[],"citation":"77 FR 41412","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2011-P-0081"],"dockets":[],"document_number":"2012-17091","effective_on":null,"end_page":41413,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/07/13/2012-17091.xml","html_url":"https://www.federalregister.gov/documents/2012/07/13/2012-17091/determination-that-chloromycetin-chloramphenicol-capsules-250-milligrams-were-withdrawn-from-sale","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-17091?publication_date=2012-07-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-07-13/2012-17091/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2104,"last_updated":"2026-06-12 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-07-13/pdf/2012-17091.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-17091.pdf?1342097527","publication_date":"2012-07-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/07/13/2012-17091.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 5 Hamburg, M. FDA's Take on the Executive Order and National Strategy to Combat Antibiotic-Resistant Bacteria re: Petition for Reconsideration from Armenpharm, Ltd","document_id":"FDA-2011-P-0081-0020"},{"title":"Attachment 4 Monaco and Holdren New executive actions to combat antibiotic resistance and protect public health re: Petition for Reconsideration from Armenpharm, Ltd","document_id":"FDA-2011-P-0081-0019"},{"title":"Attachment 3 Feltman, R. A 'superbug' Emerges in China to Remind Us That Antibiotics Won't Last Forever re: Petition for Reconsideration from Armenpharm, Ltd","document_id":"FDA-2011-P-0081-0018"},{"title":"Attachment 2 Amendment to Prior Approval Supplement for Chloramphenicol Capsules USP, 250 mg (ANDA:060851) re: Petition for Reconsideration from Armenpharm, Ltd","document_id":"FDA-2011-P-0081-0017"},{"title":"Attachment 1 Letter from Armenpharm, Ltd to FDA CDER re: Petition for Reconsideration from Armenpharm, Ltd","document_id":"FDA-2011-P-0081-0016"},{"title":"Attachment 9 - \"Approved Package Insert for Chloramphenicol Capsules, USP\" - [Armenpharm, Ltd. - Citizen Petition]","document_id":"FDA-2011-P-0081-0007"},{"title":"Attachment 5 - \"Interagency Task Force on Antimicrobial Resistance,\" Background Information from CDC and FDA - [Armenpharm, Ltd. - Citizen Petition]","document_id":"FDA-2011-P-0081-0006"},{"title":"Attachment 4 - \"Approval Application Number A062365 for Active Ingredient, Chloramphenicol Sodium Succinate - Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations\" - [Armenpharm, Ltd. - Citizen Petition]","document_id":"FDA-2011-P-0081-0005"},{"title":"Attachment 3 - \"Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications,\" Federal Register Notice, dated February 11, 2009 - [Armenpharm, Ltd. - Citizen Petition]","document_id":"FDA-2011-P-0081-0004"},{"title":"Attachment 2 - \"Letters dated September 23, 1991 and October 23, 1991 from Armenpharm, Ltd. to FDA Requesting Withdraw of Supplement S-003 to Abbreviated Antibiotic Drug Application (AADA) 60-851 for Chloramphenicol Capsules USP, 250 mg\" - [Armenpharm, Lt","document_id":"FDA-2011-P-0081-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-P-0081","supporting_documents_count":11,"docket_id":"FDA-2011-P-0081","regulation_id_number":null,"title":"Determine whether Chloramphenicol Capsules 250 mg was withdrawn from sale for reasons other than safety or effectiveness and grant permission to relist application number A060851","checked_regulationsdotgov_at":"2012-08-02T08:05:27Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":41412,"subtype":null,"title":"Determination That CHLOROMYCETIN (Chloramphenicol) Capsules, 250 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"CHLOROMYCETIN (Chloramphenicol) Capsules, 250 Milligrams","toc_subject":"Determinations that Drugs Were Withdrawn from Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":77}