{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that PROAMATINE (midodrine hydrochloride) tablets, 2.5 milligrams (mg), 5 mg, and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications (ANDAs) for midodrine hydrochloride tablets, 2.5 mg, 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/2019/10/22/2019-23014.html","cfr_references":[],"citation":"84 FR 56459","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-4466"],"dockets":[],"document_number":"2019-23014","effective_on":null,"end_page":56460,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/10/22/2019-23014.xml","html_url":"https://www.federalregister.gov/documents/2019/10/22/2019-23014/determination-that-proamatine-midodrine-hydrochloride-tablets-25-milligrams-5-milligrams-and-10","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-23014?publication_date=2019-10-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-10-22/2019-23014/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":3560,"last_updated":"2026-11-07 18:15:03 -0500"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-10-22/pdf/2019-23014.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-23014.pdf?1571661923","publication_date":"2019-10-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/10/22/2019-23014.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-N-4466","supporting_documents_count":0,"docket_id":"FDA-2019-N-4466","regulation_id_number":null,"title":"Determination That PROAMATINE (Midodrine Hydrochloride) Tablets, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","checked_regulationsdotgov_at":"2019-10-24T02:00:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":56459,"subtype":null,"title":"Determination That PROAMATINE (Midodrine Hydrochloride) Tablets, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"PROAMATINE (Midodrine Hydrochloride) Tablets, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams","toc_subject":"Determination that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":84}