{"abstract":"The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for LO MINASTRIN FE (ethinyl estradiol tablets, 0.01 milligrams (mg); ethinyl estradiol and norethindrone acetate tablets, 0.01 mg/1mg; and ferrous fumarate tablets, 75 mg), held by Allergan Pharmaceuticals International, LTD, c/o Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940 (Allergan). Allergan notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2019/10/25/2019-23309.html","cfr_references":[],"citation":"84 FR 57450","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Approval is withdrawn as of November 25, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-4310"],"dockets":[],"document_number":"2019-23309","effective_on":null,"end_page":57450,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/10/25/2019-23309.xml","html_url":"https://www.federalregister.gov/documents/2019/10/25/2019-23309/allergan-pharmaceuticals-international-ltd-withdrawal-of-approval-of-a-new-drug-application-for-lo","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-23309?publication_date=2019-10-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-10-25/2019-23309/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":207,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-10-25/pdf/2019-23309.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-23309.pdf?1571921123","publication_date":"2019-10-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/10/25/2019-23309.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-2019-N-4310","supporting_documents_count":0,"docket_id":"FDA-2019-N-4310","regulation_id_number":null,"title":"Allergan Pharmaceuticals International, LTD; Withdrawal of Approval of a New Drug Application for Lo Minastrin Fe ","checked_regulationsdotgov_at":"2019-10-31T08:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":57450,"subtype":null,"title":"Allergan Pharmaceuticals International, LTD; Withdrawal of Approval of a New Drug Application for LO MINASTRIN FE","toc_doc":"Allergan Pharmaceuticals International, LTD; Withdrawal of Approval of a New Drug Application for LO MINASTRIN FE","toc_subject":null,"topics":[],"type":"Notice","volume":84}