{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that QMIIZ (meloxicam) Orally Disintegrating Tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 (ANDAs) for QMIIZ (meloxicam) Orally Disintegrating Tablets, 7.5 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/2024/02/09/2024-02710.html","cfr_references":[],"citation":"89 FR 9156","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2023-P-4279"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-02-09","updated_at":"2024-02-09T11:00:48.824-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-P-4279-0003","allow_late_comments":null,"id":"FDA-2023-P-4279-0003","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-P-4279","title":"Request that the FDA determine whether the Reference Listed Drug (RLD) QMIIZ ODT (meloxicam) orally disintegrating tablet, 7.5 mg and 15 mg under New Drug Application (NDA) 211210 held by TERSERA was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons"}],"document_number":"2024-02710","effective_on":null,"end_page":9157,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/02/09/2024-02710.xml","html_url":"https://www.federalregister.gov/documents/2024/02/09/2024-02710/determination-that-qmiiz-meloxicam-orally-disintegrating-tablets-75-milligrams-and-15-milligrams","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-02710?publication_date=2024-02-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-02-09/2024-02710/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1092,"last_updated":"2026-04-04 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-02-09/pdf/2024-02710.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-02710.pdf?1707399937","publication_date":"2024-02-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/02/09/2024-02710.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-2023-P-4279","supporting_documents_count":0,"docket_id":"FDA-2023-P-4279","document_id":"FDA-2023-P-4279-0003","regulation_id_number":null,"title":"Request that the FDA determine whether the Reference Listed Drug (RLD) QMIIZ ODT (meloxicam) orally disintegrating tablet, 7.5 mg and 15 mg under New Drug Application (NDA) 211210 held by TERSERA was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons","checked_regulationsdotgov_at":"2024-02-10T15:00:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":9156,"subtype":null,"title":"Determination That QMIIZ (Meloxicam) Orally Disintegrating Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"QMIIZ (Meloxicam) Orally Disintegrating Tablets, 7.5 Milligrams and 15 Milligrams","toc_subject":"Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness:\n","topics":[],"type":"Notice","volume":89}