{"abstract":"The Food and Drug Administration (FDA) has determined that DIDREX (benzphetamine hydrochloride (HCl)) Tablets, 25 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness.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 benzphetamine HCl 25 mg tablets, 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/2010/03/25/2010-6593.html","cfr_references":[],"citation":"75 FR 14444","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2008-P-0215"],"dockets":[],"document_number":"2010-6593","effective_on":null,"end_page":14445,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2010/03/25/2010-6593.xml","html_url":"https://www.federalregister.gov/documents/2010/03/25/2010-6593/determination-that-didrex-benzphetamine-hydrochloride-tablets-25-milligrams-were-not-withdrawn-from","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2010-6593?publication_date=2010-03-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2010-03-25/2010-6593/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2818,"last_updated":"2026-04-03 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2010-03-25/pdf/2010-6593.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2010-03-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2010/03/25/2010-6593.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2010-03-26T13:19:27Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14444,"subtype":null,"title":"Determination That DIDREX (Benzphetamine Hydrochloride) Tablets, 25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"DIDREX (Benzphetamine Hydrochloride) Tablets, 25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_subject":"Determination:","topics":[],"type":"Notice","volume":75}