{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that CARDENE SR (nicardipine HCl) extended-release capsules, 30 milligrams (mg), 45 mg, and 60 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 nicardipine HCl extended-release capsules, 30 mg, 45 mg, and 60 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/2017/10/27/2017-23438.html","cfr_references":[],"citation":"82 FR 49840","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2017-P-2660"],"dockets":[],"document_number":"2017-23438","effective_on":null,"end_page":49841,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/10/27/2017-23438.xml","html_url":"https://www.federalregister.gov/documents/2017/10/27/2017-23438/determination-that-cardene-sr-nicardipine-hcl-extended-release-capsules-30-milligrams-45-milligrams","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-23438?publication_date=2017-10-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-10-27/2017-23438/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":721,"last_updated":"2026-09-21 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-10-27/pdf/2017-23438.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-23438.pdf?1509021980","publication_date":"2017-10-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/10/27/2017-23438.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 Jubilant Generics","document_id":"FDA-2017-P-2660-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-P-2660","supporting_documents_count":1,"docket_id":"FDA-2017-P-2660","regulation_id_number":null,"title":"Requests  that the FDA make a prompt determination that the discontinuation of the Reference Listed Drug (RLD), CARDENE® SR (NDA# 020005), was not for safety or effectiveness reasons.","checked_regulationsdotgov_at":"2017-11-16T06:00:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":49840,"subtype":null,"title":"Determination That CARDENE SR (Nicardipine HCl) Extended-Release Capsules, 30 Milligrams, 45 Milligrams, and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"CARDENE SR (Nicardipine HCl) Extended-Release Capsules, 30 Milligrams, 45 Milligrams, and 60 Milligrams","toc_subject":"Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":82}