{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that INAPSINE (droperidol) injection, 2.5 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.","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/2026/04/01/2026-06314.html","cfr_references":[],"citation":"91 FR 16203","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2025-P-0253"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2026-04-01T09:58:20.911-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-P-0253-0004","allow_late_comments":false,"id":"FDA-2025-P-0253-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-P-0253","title":"Request that the FDA make a determination if the RLD, Inapsine Injection, 2.5mg/mL (N016796) was withdrawn for safety or effectiveness reasons"}],"document_number":"2026-06314","effective_on":null,"end_page":16204,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/04/01/2026-06314.xml","html_url":"https://www.federalregister.gov/documents/2026/04/01/2026-06314/determination-that-inapsine-droperidol-injection-25-milligramsmilliliter-was-not-withdrawn-from-sale","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-06314?publication_date=2026-04-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-04-01/2026-06314/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":95,"last_updated":"2026-04-15 14:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-01/pdf/2026-06314.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06314.pdf?1774961116","publication_date":"2026-04-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/04/01/2026-06314.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-2025-P-0253","supporting_documents_count":0,"docket_id":"FDA-2025-P-0253","document_id":"FDA-2025-P-0253-0004","regulation_id_number":null,"title":"Request that the FDA make a determination if the RLD, Inapsine Injection, 2.5mg/mL (N016796) was withdrawn for safety or effectiveness reasons","checked_regulationsdotgov_at":"2026-04-02T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":16203,"subtype":null,"title":"Determination That INAPSINE (Droperidol) Injection, 2.5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Inapsine (Droperidol) Injection, 2.5 Milligrams/Milliliter","toc_subject":"Drug Products Not Withdrawn from Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":91}