{"abstract":"The Food and Drug Administration (FDA or Agency) is withdrawing the approval of abbreviated new drug application (ANDA) 077895 for Ursodiol Capsules USP, 300 milligrams (mg), held by Impax Laboratories, LLC (Impax). Impax requested withdrawal of this application and has waived its opportunity for a hearing.","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/2019/09/16/2019-19908.html","cfr_references":[],"citation":"84 FR 48625","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Approval is withdrawn as of September 16, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-3839"],"dockets":[],"document_number":"2019-19908","effective_on":null,"end_page":48625,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/09/16/2019-19908.xml","html_url":"https://www.federalregister.gov/documents/2019/09/16/2019-19908/impax-laboratories-llc-withdrawal-of-approval-of-an-abbreviated-new-drug-application-for-ursodiol","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-19908?publication_date=2019-09-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-09-16/2019-19908/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":348,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-09-16/pdf/2019-19908.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-19908.pdf?1568378716","publication_date":"2019-09-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/09/16/2019-19908.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-3839","supporting_documents_count":0,"docket_id":"FDA-2019-N-3839","regulation_id_number":null,"title":"Impax Laboratories, LLC; Withdrawal of Approval of an Abbreviated New Drug Application for Ursodiol Capsules USP, 300 Milligrams ","checked_regulationsdotgov_at":"2019-09-19T02:30:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":48625,"subtype":null,"title":"Impax Laboratories, LLC; Withdrawal of Approval of an Abbreviated New Drug Application for Ursodiol Capsules USP, 300 Milligrams","toc_doc":"Impax Laboratories, LLC; Ursodiol Capsules USP, 300 Milligrams; Withdrawal","toc_subject":"New Drug Application:","topics":[],"type":"Notice","volume":84}