{"abstract":"The Food and Drug Administration (FDA) has determined that selegiline hydrochloride (Eldepryl<Register>) 5-milligram (mg) tablet was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDA's) for selegiline hydrochloride 5-mg tablet.","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"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/1996/08/15/96-20857.html","cfr_references":[],"citation":"61 FR 42428","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket Nos. 96P-0190/CP1, 96P-0197/CP1, 96P-0251/CP1"],"dockets":[],"document_number":"96-20857","effective_on":null,"end_page":42428,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1996/08/15/96-20857/determination-that-selegiline-hydrochloride-5-milligram-tablet-was-not-withdrawn-from-sale-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/96-20857?publication_date=1996-08-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1996-08-15/96-20857/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":23,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1996-08-15/pdf/96-20857.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1996-08-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1996/08/15/96-20857.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T07:44:23Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":42428,"subtype":null,"title":"Determination That Selegiline Hydrochloride 5-Milligram Tablet Was Not Withdrawn From Sale For Reasons of Safety or Effectiveness","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":61}