{"abstract":"The Food and Drug Administration (FDA) has determined that NOVANTRONE (mitoxantrone hydrochloride) Injection, equivalent to (EQ) 25 milligrams (mg) base/12.5 milliliters (mL) and EQ 30 mg base/15 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.","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/2011/04/13/2011-8819.html","cfr_references":[],"citation":"76 FR 20685","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2008-P-0485"],"dockets":[],"document_number":"2011-8819","effective_on":null,"end_page":20686,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/04/13/2011-8819.xml","html_url":"https://www.federalregister.gov/documents/2011/04/13/2011-8819/determination-that-novantrone-mitoxantrone-hydrochloride-injection-equivalent-to-25-milligrams","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-8819?publication_date=2011-04-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-04-13/2011-8819/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1021,"last_updated":"2026-07-28 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-04-13/pdf/2011-8819.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-04-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/04/13/2011-8819.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-05-03T08:56:48Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20685,"subtype":null,"title":"Determination That NOVANTRONE (Mitoxantrone Hydrochloride) Injection, Equivalent to 25 Milligrams Base/12.5 Milliliter and Equivalent to 30 Milligrams Base/15 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"NOVANTRONE (Mitoxantrone Hydrochloride) Injection, Equivalent to 25 Milligrams Base/12.5 Milliliters, etc.","toc_subject":"Determinations that Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":76}