{"abstract":"The Food and Drug Administration (FDA, Agency, or we) has determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 famotidine) orally disintegrating tablets, 20 mg and 40 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/2026/10/27/2026-21897.html","cfr_references":[],"citation":"91 FR 67587","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2026-P-7178"],"dockets":[{"supporting_documents":[{"title":"Attachment 1 - Pepcid RPD NDA 20752 Discontinued 2002 Annual Ed.","document_id":"FDA-2026-P-7178-0003"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-10-27","updated_at":"2026-10-27T09:57:14.675-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-P-7178-0004","allow_late_comments":false,"id":"FDA-2026-P-7178-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2026-P-7178","title":"Requests that the FDA determine whether the Reference Listed Drug (RLD) PEPCID RPD™ (famotidine) ORALLY DISINTEGRATING TABLETS, 20 mg and 40 mg; New Drug Application (NDA) 020752 of MERCK RESEARCH LABORATORIES DIV MERCK CO INC. has been voluntarily withdrawn from sale for safety or efficacy reasons"}],"document_number":"2026-21897","effective_on":null,"end_page":67587,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/10/27/2026-21897.xml","html_url":"https://www.federalregister.gov/documents/2026/10/27/2026-21897/determination-that-pepcid-rpd-famotidine-orally-disintegrating-tablets-20-milligrams-and-40","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-21897?publication_date=2026-10-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-10-27/2026-21897/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":162,"last_updated":"2026-11-04 18:15:04 -0500"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-10-27/pdf/2026-21897.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-21897.pdf?1793018718","publication_date":"2026-10-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/10/27/2026-21897.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 1 - Pepcid RPD NDA 20752 Discontinued 2002 Annual Ed.","document_id":"FDA-2026-P-7178-0003"}],"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-2026-P-7178","supporting_documents_count":1,"docket_id":"FDA-2026-P-7178","document_id":"FDA-2026-P-7178-0004","regulation_id_number":null,"title":"Requests that the FDA determine whether the Reference Listed Drug (RLD) PEPCID RPD™ (famotidine) ORALLY DISINTEGRATING TABLETS, 20 mg and 40 mg; New Drug Application (NDA) 020752 of MERCK RESEARCH LABORATORIES DIV MERCK CO INC. has been voluntarily withdrawn from sale for safety or efficacy reasons","checked_regulationsdotgov_at":"2026-10-28T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":67587,"subtype":null,"title":"Determination That PEPCID RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Pepcid RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams","toc_subject":"Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":91}