{"abstract":"The Food and Drug Administration (FDA) is withdrawing approval of Bupropion Hydrochloride (HCl) Extended-Release Tablets, 300 Milligrams (mg) (Bupropion HCl Extended-Release Tablets 300 mg), under Abbreviated New Drug Application (ANDA) 77-415, held by Impax Laboratories, Inc. (Impax), 30831 Huntwood Ave., Hayward, CA 94544, and marketed under the name BUDEPRION XL. Impax has voluntarily requested that approval for this product be withdrawn and waived its opportunity for a hearing.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human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/2013/03/18/2013-06144.html","cfr_references":[],"citation":"78 FR 16685","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective March 18, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0233"],"dockets":[],"document_number":"2013-06144","effective_on":"2013-03-18","end_page":16685,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/03/18/2013-06144.xml","html_url":"https://www.federalregister.gov/documents/2013/03/18/2013-06144/impax-laboratories-inc-withdrawal-of-approval-of-bupropion-hydrochloride-extended-release-tablets","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-06144?publication_date=2013-03-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-03-18/2013-06144/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":1076,"last_updated":"2026-04-05 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-03-18/pdf/2013-06144.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-06144.pdf?1363352033","publication_date":"2013-03-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/03/18/2013-06144.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-2013-N-0233","supporting_documents_count":0,"docket_id":"FDA-2013-N-0233","regulation_id_number":null,"title":"Impax Laboratories, Inc.; Withdrawal of Approval of Bupropion Hydrochloride Extended-Release Tablets, 300 Milligrams","checked_regulationsdotgov_at":"2013-04-07T06:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":16685,"subtype":null,"title":"Impax Laboratories, Inc.; Withdrawal of Approval of Bupropion Hydrochloride Extended-Release Tablets, 300 Milligrams","toc_doc":"Impax Laboratories, Inc.","toc_subject":"Withdrawals of Approvals of Bupropion Hydrochloride Extended-Release Tablets:","topics":[],"type":"Notice","volume":78}