{"abstract":"The Food and Drug Administration (FDA) has determined that DIAMOX (acetazolamide) intravenous, 500 milligrams (mg) base/vial, and DIAMOX (acetazolamide) tablets, 125 mg and 250 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products, 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/2014/10/28/2014-25534.html","cfr_references":[],"citation":"79 FR 64201","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2014-P-0979"],"dockets":[],"document_number":"2014-25534","effective_on":null,"end_page":64202,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/10/28/2014-25534.xml","html_url":"https://www.federalregister.gov/documents/2014/10/28/2014-25534/determination-that-diamox-acetazolamide-intravenous-500-milligrams-basevial-and-diamox-acetazolamide","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-25534?publication_date=2014-10-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-10-28/2014-25534/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":3098,"last_updated":"2026-04-05 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-10-28/pdf/2014-25534.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-25534.pdf?1414441482","publication_date":"2014-10-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/10/28/2014-25534.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-P-0979","supporting_documents_count":0,"docket_id":"FDA-2014-P-0979","regulation_id_number":null,"title":"Find that Duramed Pharms Barr Discounted DIAMOX, for Reasons Unrelated to Safety and Efficacy; Permit Emcure to Maintain its ANDA Seeking Approval to Market Competing Generic Versions; and Refrain From Delaying Approval of Emcure's ANDA Based on any Disco","checked_regulationsdotgov_at":"2015-01-12T19:47:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":64201,"subtype":null,"title":"Determination That DIAMOX (Acetazolamide) Intravenous, 500 Milligrams Base/Vial, and DIAMOX (Acetazolamide) Tablets, 125 Milligrams and 250 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"DIAMOX (Acetazolamide) Intravenous, 500 Milligrams Base/Vial, and DIAMOX (Acetazolamide) Tablets, 125 and 250 Milligrams","toc_subject":"Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":79}