{"abstract":"The Food and Drug Administration (FDA, Agency, or we) has determined that BUSPAR (buspirone hydrochloride) capsules, 5 milligrams (mg), 7.5 mg, 10 mg, and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDA) for buspirone hydrochloride capsules, 5 mg, 7.5 mg, 10 mg, and 15 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/2023/06/08/2023-12247.html","cfr_references":[],"citation":"88 FR 37548","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2023-P-0120"],"dockets":[{"supporting_documents":[{"title":"Attachment 1 - Orange Book listing for Buspar Capsules RE: Citizen Petition from Epic Pharma LLC","document_id":"FDA-2023-P-0120-0003"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-06-08","updated_at":"2023-06-08T10:56:36.686-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-P-0120-0004","allow_late_comments":null,"id":"FDA-2023-P-0120-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2023-P-0120","title":"Requests that the FDA determine whether Buspar (Buspirone Hydrochloride) Capsules 5 mg, 7.5 mg, 10 mg, and 15 mg approved under NDA 021190 held by Bristol Myers Squibb Co Pharmaceutical Research Institute have been withdrawn for safety or effectiveness reasons.; CLOSED"}],"document_number":"2023-12247","effective_on":null,"end_page":37548,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/06/08/2023-12247.xml","html_url":"https://www.federalregister.gov/documents/2023/06/08/2023-12247/determination-that-buspar-buspirone-hydrochloride-capsules-5-milligrams-75-milligrams-10-milligrams","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-12247?publication_date=2023-06-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-06-08/2023-12247/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":2688,"last_updated":"2026-05-11 10:15:15 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-06-08/pdf/2023-12247.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-12247.pdf?1686141922","publication_date":"2023-06-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/06/08/2023-12247.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 1 - Orange Book listing for Buspar Capsules RE: Citizen Petition from Epic Pharma LLC","document_id":"FDA-2023-P-0120-0003"}],"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-2023-P-0120","supporting_documents_count":1,"docket_id":"FDA-2023-P-0120","document_id":"FDA-2023-P-0120-0004","regulation_id_number":null,"title":"Requests that the FDA determine whether Buspar (Buspirone Hydrochloride) Capsules 5 mg, 7.5 mg, 10 mg, and 15 mg approved under NDA 021190 held by Bristol Myers Squibb Co Pharmaceutical Research Institute have been withdrawn for safety or effectiveness reasons.; CLOSED","checked_regulationsdotgov_at":"2023-06-09T13:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":37548,"subtype":null,"title":"Determination That BUSPAR (Buspirone Hydrochloride) Capsules, 5 Milligrams, 7.5 Milligrams, 10 Milligrams, and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Determination That BUSPAR (Buspirone Hydrochloride) Capsules, 5 Milligrams, 7.5 Milligrams, 10 Milligrams, and 15 Milligrams, Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness","toc_subject":null,"topics":[],"type":"Notice","volume":88}