{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 milligrams (mg) and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, if all other legal and regulatory requirements are met.","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/2026/09/03/2026-18023.html","cfr_references":[],"citation":"91 FR 56654","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2025-P-1372"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-09-03","updated_at":"2026-09-03T09:04:06.443-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-P-1372-0004","allow_late_comments":false,"id":"FDA-2025-P-1372-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-P-1372","title":"Requests the FDA to determine whether Phenaphen w/ Codeine No. 3 and Phenaphen w/ Codeine No. 4 capsules, ABBREVIATED NEW DRUG APPLICATION NOS. A084445 and A084446 were voluntarily withdrawn from sale for safety or efficacy reasons"}],"document_number":"2026-18023","effective_on":null,"end_page":56655,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/09/03/2026-18023.xml","html_url":"https://www.federalregister.gov/documents/2026/09/03/2026-18023/determination-that-phenaphen-with-codeine-no-3-acetaminophen-codeine-phosphate-oral-capsules-325","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-18023?publication_date=2026-09-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-09-03/2026-18023/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":220,"last_updated":"2026-10-24 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-03/pdf/2026-18023.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18023.pdf?1788353112","publication_date":"2026-09-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/09/03/2026-18023.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2025-P-1372","supporting_documents_count":0,"docket_id":"FDA-2025-P-1372","document_id":"FDA-2025-P-1372-0004","regulation_id_number":null,"title":"Requests the FDA to determine whether Phenaphen w/ Codeine No. 3 and Phenaphen w/ Codeine No. 4 capsules, ABBREVIATED NEW DRUG APPLICATION NOS. A084445 and A084446 were voluntarily withdrawn from sale for safety or efficacy reasons","checked_regulationsdotgov_at":"2026-09-04T15:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56654,"subtype":null,"title":"Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams","toc_subject":"Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":91}