{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that the drug product listed in this document was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.","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/2015/06/23/2015-15327.html","cfr_references":[],"citation":"80 FR 35959","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-0002"],"dockets":[],"document_number":"2015-15327","effective_on":null,"end_page":35959,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/06/23/2015-15327.xml","html_url":"https://www.federalregister.gov/documents/2015/06/23/2015-15327/determination-that-abilify-aripiprazole-solution-was-not-withdrawn-from-sale-for-reasons-of-safety","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-15327?publication_date=2015-06-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-06-23/2015-15327/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":1407,"last_updated":"2026-08-26 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-06-23/pdf/2015-15327.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-15327.pdf?1434977156","publication_date":"2015-06-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/06/23/2015-15327.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"FONSI for sN 141-361, approved December 7, 2015","document_id":"FDA-2015-N-0002-0069"},{"title":"FONSI for  oN 141-453, approved December 8, 2015","document_id":"FDA-2015-N-0002-0068"},{"title":"FOI Summary for sN 141-361, approved December 7, 2015","document_id":"FDA-2015-N-0002-0067"},{"title":"FOI Summary for sN 141-258, approved December 2, 2015","document_id":"FDA-2015-N-0002-0066"},{"title":"FOI Summary for oN 141-453, approved December 8, 2015","document_id":"FDA-2015-N-0002-0065"},{"title":"EA for sN 141-361, approved December 7, 2015","document_id":"FDA-2015-N-0002-0064"},{"title":"EA for oN 141-453, approved December 8, 2015","document_id":"FDA-2015-N-0002-0063"},{"title":"Finding of No Significant Impact (FONSI) for SAFE-GUARD AQUASOL\n(fenbendazole oral suspension) in\nChickens","document_id":"FDA-2015-N-0002-0056"},{"title":"FREEDOM OF INFORMATION SUMMARY  NADA 141-442 LUTALYSE HighCon Injection Dinoprost Tromethamine Injection Lactating dairy cows, beef cows, beef heifers, and replacement dairy heifers","document_id":"FDA-2015-N-0002-0055"},{"title":"FREEDOM OF INFORMATION SUMMARY NADA 141-449 SAFE-GUARD AquaSol Fenbendazole oral suspension Broiler chickens, replacement chickens intended to become breeding chickens, and breeding chickens","document_id":"FDA-2015-N-0002-0054"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-0002","supporting_documents_count":51,"docket_id":"FDA-2015-N-0002","regulation_id_number":null,"title":"NADA/ANADA Notices","checked_regulationsdotgov_at":"2015-07-13T06:00:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":35959,"subtype":null,"title":"Determination That ABILIFY (Aripiprazole) Solution Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"ABILIFY (Aripiprazole)","toc_subject":"Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":80}