{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that the potassium chloride drug products listed in this notice were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these drug products, if all other legal and regulatory requirements are met.","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/2020/03/17/2020-05442.html","cfr_references":[],"citation":"85 FR 15194","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2019-P-4523"],"dockets":[],"document_number":"2020-05442","effective_on":null,"end_page":15195,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/03/17/2020-05442.xml","html_url":"https://www.federalregister.gov/documents/2020/03/17/2020-05442/determination-that-potassium-chloride-in-5-dextrose-and-0225-sodium-chloride-injection-5","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-05442?publication_date=2020-03-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-03-17/2020-05442/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":283,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-05442.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-05442.pdf?1584362748","publication_date":"2020-03-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/03/17/2020-05442.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment A Orange Book Listing of Potassium Chloride in Dextrose 5% and Sodium Chloride 0.225% - NDA 018365 (September 26, 2019) re Citizen Petition from Fresenius Kabi USA, LLC","document_id":"FDA-2019-P-4523-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-P-4523","supporting_documents_count":1,"docket_id":"FDA-2019-P-4523","regulation_id_number":null,"title":"Requests that the Commissioner of FDA Makes a Determination Whether Drug Product under NDA 018365 held by ICU Medical Inc. Potassium Chloride (5mEq, 10mEq, 15mEq, 20mEq, 30mEq, and 40mEq) in Dextrose 5% and Sodium Chloride 0.225% in Plastic Containers was Withdrawn from the Market Place for Reasons Other than Safety or Efficacy - CLOSED","checked_regulationsdotgov_at":"2020-03-19T08:30:47Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":15194,"subtype":null,"title":"Determination That Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Injection, 5 Milliequivalents, 10 Milliequivalents, 15 Milliequivalents, 20 Milliequivalents, 30 Milliequivalents, and 40 Milliequivalents, in Plastic Containers, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":85}