{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day.\" This guidance explains how FDA intends to determine eligibility for 180-day exclusivity when multiple substantially complete abbreviated new drug applications (ANDAs) that contain a paragraph IV certification to the same patent(s) are submitted on the same day or when paragraph IV certifications are submitted in an amendment or supplement on the same day.","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/2003/08/01/03-19590.html","cfr_references":[],"citation":"68 FR 45252","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. 2003D-0325"],"dockets":[],"document_number":"03-19590","effective_on":null,"end_page":45256,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2003/08/01/03-19590.xml","html_url":"https://www.federalregister.gov/documents/2003/08/01/03-19590/guidance-for-industry-on-180-day-exclusivity-when-multiple-abbreviated-new-drug-applications-are","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/03-19590?publication_date=2003-08-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2003-08-01/03-19590/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":578,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-08-01/pdf/03-19590.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2003-08-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2003/08/01/03-19590.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45252,"subtype":null,"title":"Guidance for Industry on 180-Day Exclusivity When Multiple Abbreviated New Drug Applications Are Submitted on the Same Day; Availability","toc_doc":"180-day exclusivity when multiple abbreviated new drug applications are submitted on same day","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":68}