{"abstract":"The Food and Drug Administration (FDA) is withdrawing approval of 44 new drug applications (NDAs) and 158 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2016/10/04/2016-23893.html","cfr_references":[],"citation":"81 FR 68427","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective Date: November 3, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-0002"],"dockets":[],"document_number":"2016-23893","effective_on":"2016-11-03","end_page":68432,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/10/04/2016-23893.xml","html_url":"https://www.federalregister.gov/documents/2016/10/04/2016-23893/hospira-inc-et-al-withdrawal-of-approval-of-44-new-drug-applications-and-158-abbreviated-new-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-23893?publication_date=2016-10-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-10-04/2016-23893/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":3376,"last_updated":"2026-10-24 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-10-04/pdf/2016-23893.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-23893.pdf?1475498744","publication_date":"2016-10-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/10/04/2016-23893.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FOI Summary sN 141-452 approved December 12 2016","document_id":"FDA-2016-N-0002-0046"},{"title":"FOI Summary sN 141-443, approved November 16, 2016","document_id":"FDA-2016-N-0002-0045"},{"title":"FOI Summary oN 141-475 approved December 29 2016","document_id":"FDA-2016-N-0002-0044"},{"title":"FOI Summary oN 141-474 approved November 10 2016","document_id":"FDA-2016-N-0002-0043"},{"title":"FOI Summary oN 141-473 approved December 16 2016","document_id":"FDA-2016-N-0002-0042"},{"title":"FOI Summary oA 200-589 approved December 21 2016","document_id":"FDA-2016-N-0002-0041"},{"title":"FOI Summary oA 200-596, approved May 24, 2016 re  New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship","document_id":"FDA-2016-N-0002-0027"},{"title":"FOI Summary oN 141-463, approved May 17, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship","document_id":"FDA-2016-N-0002-0026"},{"title":"FOI Summary oN 141-457, approved May 16, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship","document_id":"FDA-2016-N-0002-0025"},{"title":"FOI Summary oN 141-439, approved May 2, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship","document_id":"FDA-2016-N-0002-0024"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-0002","supporting_documents_count":27,"docket_id":"FDA-2016-N-0002","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2016-10-24T06:00:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":68427,"subtype":null,"title":"Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications","toc_doc":"Hospira, Inc. et al.; Withdrawal","toc_subject":"New Drug Applications:","topics":[],"type":"Notice","volume":81}