{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 milliliters (mL); HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL; HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 10,000 units/100 mL; and HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL under new drug application (NDA) 019802 were not withdrawn from sale for reasons of safety or effectiveness.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 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/2025/08/26/2025-16349.html","cfr_references":[],"citation":"90 FR 41572","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2022-P-0060"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2025-08-26T12:56:15.433-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-P-0060-0003","allow_late_comments":false,"id":"FDA-2022-P-0060-0003","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-P-0060","title":"Requests that the FDA determine that Heparin Sodium in Sodium Chloride Injection in Plastic Container products listed below, approved under NDA 019802, held by B. Braun Medical Inc were not withdrawn from marketing for safety or effectiveness reasons."}],"document_number":"2025-16349","effective_on":null,"end_page":41573,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/08/26/2025-16349.xml","html_url":"https://www.federalregister.gov/documents/2025/08/26/2025-16349/determination-that-four-heparin-sodium-in-sodium-chloride-in-plastic-container-heparin-sodium-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-16349?publication_date=2025-08-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-08-26/2025-16349/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":135,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-26/pdf/2025-16349.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-16349.pdf?1756125931","publication_date":"2025-08-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/08/26/2025-16349.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-P-0060","supporting_documents_count":0,"docket_id":"FDA-2022-P-0060","document_id":"FDA-2022-P-0060-0003","regulation_id_number":null,"title":"Requests that the FDA determine that Heparin Sodium in Sodium Chloride Injection in Plastic Container products listed below, approved under NDA 019802, held by B. Braun Medical Inc were not withdrawn from marketing for safety or effectiveness reasons.","checked_regulationsdotgov_at":"2025-08-27T19:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":41572,"subtype":null,"title":"Determination That Four Heparin Sodium In Sodium Chloride In Plastic Container (Heparin Sodium) Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Heparin Sodium in Sodium Chloride in Plastic Container (Heparin Sodium)","toc_subject":"Drug Products not Withdrawn From Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":90}