{"abstract":"The Food and Drug Administration (FDA) is withdrawing approval of 13 new drug applications (NDAs) and 7 abbreviated new drug applications (ANDAs) for products containing phenylpropanolamine. The basis for the withdrawals is that the products are no longer considered safe due to the association of phenylpropanolamine use with increased risk of hemorrhagic stroke. The holders of these NDAs and ANDAs have waived their 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/2014/02/20/2014-03596.html","cfr_references":[],"citation":"79 FR 9744","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective February 20, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2001-N-0274 (formerly 01N-0196)"],"dockets":[],"document_number":"2014-03596","effective_on":"2014-02-20","end_page":9745,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/02/20/2014-03596.xml","html_url":"https://www.federalregister.gov/documents/2014/02/20/2014-03596/phenylpropanolamine-withdrawal-of-approval-of-13-new-drug-applications-and-7-abbreviated-new-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-03596?publication_date=2014-02-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-02-20/2014-03596/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1486,"last_updated":"2026-04-11 06:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-02-20/pdf/2014-03596.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-03596.pdf?1392818323","publication_date":"2014-02-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/02/20/2014-03596.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-03-12T08:13:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":9744,"subtype":null,"title":"Phenylpropanolamine; Withdrawal of Approval of 13 New Drug Applications and 7 Abbreviated New Drug Applications","toc_doc":"Phenylpropanolamine; Withdrawal of Approval","toc_subject":"New Drug and Abbreviated New Drug Applications:","topics":[],"type":"Notice","volume":79}