{"abstract":"The Food and Drug Administration (FDA) has determined that Potassium Citrate, 10 milliequivalents/packet (mEq/packet) and 20 mEq/ packet, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Potassium Citrate, 10 mEq/packet and 20 mEq/packet, 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/2013/10/23/2013-24780.html","cfr_references":[],"citation":"78 FR 63228","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2013-P-0503"],"dockets":[],"document_number":"2013-24780","effective_on":null,"end_page":63229,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/10/23/2013-24780.xml","html_url":"https://www.federalregister.gov/documents/2013/10/23/2013-24780/determination-that-potassium-citrate-10-milliequivalentspacket-and-20-milliequivalentspacket-was-not","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-24780?publication_date=2013-10-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-10-23/2013-24780/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":477,"last_updated":"2026-04-03 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-10-23/pdf/2013-24780.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-24780.pdf?1382446286","publication_date":"2013-10-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/10/23/2013-24780.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2013-11-12T06:03:27Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":63228,"subtype":null,"title":"Determination That Potassium Citrate, 10 Milliequivalents/Packet and 20 Milliequivalents/Packet, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Potassium Citrate, 10 Milliequivalents/Packet and 20 Milliequivalents/Packet","toc_subject":"Products Not Withdrawn from Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":78}