{"abstract":"The Food and Drug Administration (FDA) has determined that REV-EYES (dapiprazole hydrochloride ophthalmic solution), 0.5%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dapiprazole hydrochloride ophthalmic solution, 0.5%, 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/2013/05/13/2013-11285.html","cfr_references":[],"citation":"78 FR 27971","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2012-P-1000"],"dockets":[],"document_number":"2013-11285","effective_on":null,"end_page":27971,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/05/13/2013-11285.xml","html_url":"https://www.federalregister.gov/documents/2013/05/13/2013-11285/determination-that-rev-eyes-dapiprazole-hydrochloride-ophthalmic-solution-05-was-not-withdrawn-from","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-11285?publication_date=2013-05-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-05-13/2013-11285/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":6332,"last_updated":"2026-08-23 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-05-13/pdf/2013-11285.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-11285.pdf?1368190152","publication_date":"2013-05-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/05/13/2013-11285.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-2012-P-1000","supporting_documents_count":0,"docket_id":"FDA-2012-P-1000","regulation_id_number":null,"title":"Determine That Discontinued Reference Listed Drug Dapiprazole Hydrochloride Ophthalmic Solution Was Not Withdrawn For Safety or Effectiveness Reasons - CLOSED","checked_regulationsdotgov_at":"2013-06-02T06:00:19Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27971,"subtype":null,"title":"Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"REVEYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5 Percent","toc_subject":"Determinations that Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":78}