{"abstract":"The Food and Drug Administration (FDA) has determined that PREZISTA (darunavir) Tablets, 300 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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) for darunavir tablets, 300 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/2012/01/18/2012-847.html","cfr_references":[],"citation":"77 FR 2555","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2011-P-0756"],"dockets":[],"document_number":"2012-847","effective_on":null,"end_page":2555,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/01/18/2012-847.xml","html_url":"https://www.federalregister.gov/documents/2012/01/18/2012-847/determination-that-prezista-darunavir-tablets-300-milligrams-was-not-withdrawn-from-sale-for-reasons","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-847?publication_date=2012-01-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-01-18/2012-847/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":235,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-01-18/pdf/2012-847.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-00847.pdf?1326808416","publication_date":"2012-01-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/01/18/2012-847.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2012-02-26T19:30:50Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":2555,"subtype":null,"title":"Determination That PREZISTA (darunavir) Tablets, 300 Milligrams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"PREZISTA (darunavir) Tablets, 300 Milligrams","toc_subject":"Determinations That Drugs Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":77}