{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-14", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "32", "submission_status": "AP", "submission_status_date": "20190823", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "59845", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022406Orig1s034, 202439Orig1s032ltr.pdf", "date": "20190827", "type": "Letter" }, { "id": "59866", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s034,202439s032lbl.pdf", "date": "20190828", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "24", "submission_status": "AP", "submission_status_date": "20180208", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "52527", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s024lbl.pdf", "date": "20180209", "type": "Label" }, { "id": "52546", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202439Orig1s024ltr.pdf", "date": "20180209", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "20161005", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "45541", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202439Orig1s020ltr.pdf", "date": "20161014", "type": "Letter" }, { "id": "47281", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202439s020lbl.pdf", "date": "20170222", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "12", "submission_status": "AP", "submission_status_date": "20140212", "review_priority": "N/A", "submission_class_code": "REMS", "submission_class_code_description": "REMS", "application_docs": [ { "id": "32261", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202439Orig1s012ltr.pdf", "date": "20140213", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "20130807", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "10049", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202439Orig1s008ltr.pdf", "date": "20130808", "type": "Letter" }, { "id": "19349", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202439s008lbl.pdf", "date": "20130809", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "29", "submission_status": "AP", "submission_status_date": "20190201", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "57412", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202439s029lbl.pdf", "date": "20190204", "type": "Label" }, { "id": "57534", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202439Orig1s029ltr.pdf", "date": "20190213", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "35", "submission_status": "AP", "submission_status_date": "20210823", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "68454", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022406Orig1s037;%20202439Orig1s035ltr.pdf", "date": "20210825", "type": "Letter" }, { "id": "68459", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202439_S035_022406S037lbl.pdf", "date": "20210825", "type": "Label" }, { "id": "70093", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/202439Orig1s035.pdf", "date": "20220204", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "27", "submission_status": "AP", "submission_status_date": "20180627", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "54763", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s027lbl.pdf", "date": "20180705", "type": "Label" }, { "id": "54835", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202439Orig1s027ltr.pdf", "date": "20180706", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "20160906", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "45273", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202439Orig1s019ltr.pdf", "date": "20160908", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "33", "submission_status": "AP", "submission_status_date": "20191011", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "60544", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s033,202439s033lbl.pdf", "date": "20191011", "type": "Label" }, { "id": "60565", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022406Orig1s033, 202439Orig1s033ltr.pdf", "date": "20191015", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "25", "submission_status": "AP", "submission_status_date": "20181011", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "55878", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s025lbl.pdf", "date": "20181011", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "20160506", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "40185", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202439s017lbl.pdf", "date": "20160509", "type": "Label" }, { "id": "32262", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202439Orig1s017ltr.pdf", "date": "20160509", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "31", "submission_status": "AP", "submission_status_date": "20200310", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "62116", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202439Orig1s031,022406Orig1s035ltr.pdf", "date": "20200311", "type": "Letter" }, { "id": "62123", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202439s031,022406s035lbl.pdf", "date": "20200311", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "23", "submission_status": "AP", "submission_status_date": "20180727", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "55047", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202439Orig1s023Ltr.pdf", "date": "20180730", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "15", "submission_status": "AP", "submission_status_date": "20150910", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "40184", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202439s015lbl.pdf", "date": "20150911", "type": "Label" }, { "id": "10050", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202439Orig1s015ltr.pdf", "date": "20150914", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "21", "submission_status": "AP", "submission_status_date": "20170329", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "47786", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202439s021lbl.pdf", "date": "20170330", "type": "Label" }, { "id": "47841", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202439Orig1s021ltr.pdf", "date": "20170403", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "13", "submission_status": "AP", "submission_status_date": "20150216", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "11", "submission_status": "AP", "submission_status_date": "20140515", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "20121105", "review_priority": "N/A", "submission_class_code": "REMS", "submission_class_code_description": "REMS" }, { "submission_type": "SUPPL", "submission_number": "5", "submission_status": "AP", "submission_status_date": "20120712", "review_priority": "N/A", "submission_class_code": "REMS", "submission_class_code_description": "REMS" }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "20130403", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "38", "submission_status": "AP", "submission_status_date": "20220301", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "70356", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022406Orig1s039, 202439Orig1s038correctedltr.pdf", "date": "20220519", "type": "Letter" }, { "id": "70374", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022406Orig1s039,202439Orig1s038correctedlbl.pdf", "date": "20220302", "type": "Label" }, { "id": "70375", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022406s039,202439s038lbl.pdf#page=77", "date": "20220302", "type": "Medication Guide" } ] }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20111205", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "36", "submission_status": "AP", "submission_status_date": "20210128", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "66022", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022406Orig1s036,202439Orig1s036ltr.pdf", "date": "20210129", "type": "Letter" }, { "id": "66025", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022406s036,202439s036lbl.pdf", "date": "20210129", "type": "Label" } ] }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20111104", "review_priority": "STANDARD", "submission_class_code": "TYPE 9", "submission_class_code_description": "Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval", "application_docs": [ { "id": "43402", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202439toc.html", "date": "20140603", "type": "Review" }, { "id": "19348", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202439s000lbl.pdf", "date": "20140603", "type": "Label" }, { "id": "32260", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202439s000ltr.pdf", "date": "20140603", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "34", "submission_status": "AP", "submission_status_date": "20191115", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "60902", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022406Orig1s027, 202439Orig1s034ltr.pdf", "date": "20191119", "type": "Letter" }, { "id": "61023", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022406s027,202439s034lbl.pdf", "date": "20191122", "type": "Label" } ] } ], "application_number": "NDA202439", "sponsor_name": "JANSSEN PHARMS", "products": [ { "product_number": "003", "reference_drug": "No", "brand_name": "XARELTO", "active_ingredients": [ { "name": "RIVAROXABAN", "strength": "20MG" } ], "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription" }, { "product_number": "001", "reference_drug": "No", "brand_name": "XARELTO", "active_ingredients": [ { "name": "RIVAROXABAN", "strength": "10MG" } ], "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription" }, { "product_number": "004", "reference_drug": "No", "brand_name": "XARELTO", "active_ingredients": [ { "name": "RIVAROXABAN", "strength": "2.5MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription" }, { "product_number": "002", "reference_drug": "No", "brand_name": "XARELTO", "active_ingredients": [ { "name": "RIVAROXABAN", "strength": "15MG" } ], "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription" } ] } ] }