{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that ONFI (clobazam) tablets, 5 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to the drug product, 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/2019/04/02/2019-06381.html","cfr_references":[],"citation":"84 FR 12616","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2018-P-2754"],"dockets":[],"document_number":"2019-06381","effective_on":null,"end_page":12617,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/04/02/2019-06381.xml","html_url":"https://www.federalregister.gov/documents/2019/04/02/2019-06381/determination-that-onfi-clobazam-tablets-5-milligrams-was-not-withdrawn-from-sale-for-reasons-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-06381?publication_date=2019-04-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-04-02/2019-06381/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":436,"last_updated":"2026-07-27 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-04-02/pdf/2019-06381.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-06381.pdf?1554122725","publication_date":"2019-04-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/04/02/2019-06381.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment A- Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations re: Citizen Petition from Ascend Laboratories LLC","document_id":"FDA-2018-P-2754-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-P-2754","supporting_documents_count":1,"docket_id":"FDA-2018-P-2754","regulation_id_number":null,"title":"Request the FDA determine whether ONFI (clobazam) tablets 5mg, ( NDA N20267) held by Lundbeck Pharmaceutical LLC has been voluntarily withdrawn or witheld from sale for reason of safety or efficacy.; CLOSED","checked_regulationsdotgov_at":"2019-04-22T10:00:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":12616,"subtype":null,"title":"Determination That ONFI (Clobazam) Tablets, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"ONFI (Clobazam) Tablets, 5 Milligrams, was not Withdrawn from Sale for Reasons of Safety or Effectiveness","toc_subject":"Determination:","topics":[],"type":"Notice","volume":84}