{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that GYNOREST (dydrogesterone) oral tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 GYNOREST (dydrogesterone) oral tablets, 5 mg and 10 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/2017/09/06/2017-18816.html","cfr_references":[],"citation":"82 FR 42101","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2016-P-2675"],"dockets":[],"document_number":"2017-18816","effective_on":null,"end_page":42101,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/09/06/2017-18816.xml","html_url":"https://www.federalregister.gov/documents/2017/09/06/2017-18816/determination-that-gynorest-dydrogesterone-oral-tablets-5-milligrams-and-10-milligrams-were-not","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-18816?publication_date=2017-09-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-09-06/2017-18816/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":10007,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-09-06/pdf/2017-18816.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-18816.pdf?1504615553","publication_date":"2017-09-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/09/06/2017-18816.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 1 Orange Book: Approved Drug Products with Therapeutic\nEquivalence Evaluations re Citizen Petition from Foley & Lardner LLP","document_id":"FDA-2016-P-2675-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-P-2675","supporting_documents_count":1,"docket_id":"FDA-2016-P-2675","regulation_id_number":null,"title":"Request that the FDA determine if the listed RLD product Gynorest, N017388, NDA Holder - Solvay Pharmaceuticals, was discontinued for safety or effectiveness reasons.; CLOSED","checked_regulationsdotgov_at":"2017-09-26T06:00:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":42101,"subtype":null,"title":"Determination That GYNOREST (Dydrogesterone) Oral Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"GYNOREST (Dydrogesterone) Oral Tablets, 5 Milligrams and 10 Milligrams","toc_subject":"Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":82}