{"abstract":"The Food and Drug Administration (FDA) refuses to approve supplemental new drug applications (NDA's) for Tuss-Ornade Spansules and Liquid containing caramiphen edisylate and phenylpropanolamine hydrochloride. The basis for FDA's refusal to approve these products is that there is a lack of substantial evidence that caramiphen edisylate is effective.","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/2000/07/07/00-17197.html","cfr_references":[],"citation":"65 FR 42017","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective July 7, 2000.","disposition_notes":null,"docket_ids":["Docket No. 83N-0118","DESI 6514"],"dockets":[],"document_number":"00-17197","effective_on":"2000-07-07","end_page":42017,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2000/07/07/00-17197.xml","html_url":"https://www.federalregister.gov/documents/2000/07/07/00-17197/oral-prescription-drugs-offered-for-relief-of-symptoms-of-cough-cold-or-allergy-drug-efficacy-study","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/00-17197?publication_date=2000-07-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2000-07-07/00-17197/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":997,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2000-07-07/pdf/00-17197.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2000-07-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2000/07/07/00-17197.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":42017,"subtype":null,"title":"Oral Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or Allergy; Drug Efficacy Study Implementation; Caramiphen Edisylate; Final Actions on Supplemental New Drug Applications","toc_doc":"Caramiphen edisylate; refusal","toc_subject":"Human drugs:","topics":[],"type":"Notice","volume":65}