{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that PREVACID IV (lansoprazole) intravenous injection, 30 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for lansoprazole intravenous injection, 30 mg/vial, 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/2016/09/08/2016-21551.html","cfr_references":[],"citation":"81 FR 62143","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2016-P-1037"],"dockets":[],"document_number":"2016-21551","effective_on":null,"end_page":62144,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/09/08/2016-21551.xml","html_url":"https://www.federalregister.gov/documents/2016/09/08/2016-21551/determination-that-prevacid-iv-lansoprazole-intravenous-injection-30-milligramsvial-was-not","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-21551?publication_date=2016-09-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-09-08/2016-21551/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1689,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-09-08/pdf/2016-21551.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-21551.pdf?1473252371","publication_date":"2016-09-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/09/08/2016-21551.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 1 - Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations for Prevacid IV re Citizen Petition from Rose Zhao, Emprise Pharma","document_id":"FDA-2016-P-1037-0002"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-P-1037","supporting_documents_count":1,"docket_id":"FDA-2016-P-1037","regulation_id_number":null,"title":"Request FDA to make a determination that the product Prevacid IV 30 mg/vial was not discontinued for safety or efficacy reasons, and to allow us to use the discontinued RLD.","checked_regulationsdotgov_at":"2016-09-28T06:00:24Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":62143,"subtype":null,"title":"Determination That PREVACID IV (Lansoprazole) Intravenous Injection, 30 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"PREVACID IV (Lansoprazole) Intravenous Injection, 30 Milligrams/Vial","toc_subject":"Determinations That Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":81}