{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) has determined that SERENTIL (mesoridazine besylate) tablets, 10 milligrams (mg), 25 mg, 50 mg, and 100 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mesoridazine besylate tablets, 10 mg, 25 mg, 50 mg, and 100 mg, 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/2021/04/01/2021-06722.html","cfr_references":[],"citation":"86 FR 17159","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2020-P-1881"],"dockets":[],"document_number":"2021-06722","effective_on":null,"end_page":17159,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/04/01/2021-06722.xml","html_url":"https://www.federalregister.gov/documents/2021/04/01/2021-06722/determination-that-serentil-mesoridazine-besylate-tablets-10-milligrams-25-milligrams-50-milligrams","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-06722?publication_date=2021-04-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-04-01/2021-06722/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":640,"last_updated":"2026-04-04 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-04-01/pdf/2021-06722.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-06722.pdf?1617194736","publication_date":"2021-04-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/04/01/2021-06722.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-2020-P-1881","supporting_documents_count":0,"docket_id":"FDA-2020-P-1881","document_id":"FDA-2020-P-1881-0004","regulation_id_number":null,"title":"Requests that the FDA determine whether Novartis’ Serentil (mesoridazine besylate) tablet approved under NDA 016774 was withdrawn for safety and/or effectiveness reasons.","checked_regulationsdotgov_at":"2021-04-02T03:30:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":17159,"subtype":null,"title":"Determination That SERENTIL (Mesoridazine Besylate) Tablets, 10 Milligrams, 25 Milligrams, 50 Milligrams, and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"SERENTIL (Mesoridazine Besylate) Tablets, 10 Milligrams, 25 Milligrams, 50 Milligrams, and 100 Milligrams","toc_subject":"Determination That Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness:\n","topics":[],"type":"Notice","volume":86}