{ "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": "2026-08-28", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "48", "submission_status": "AP", "submission_status_date": "20140225", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "28055", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021536Orig1s048ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "62", "submission_status": "AP", "submission_status_date": "20221208", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "72837", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s062lbl.pdf", "date": "20221209", "type": "Label" }, { "id": "72847", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021536Orig1s062ltr.pdf", "date": "20221209", "type": "Letter" }, { "id": "72867", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s062lbl.pdf", "date": "20221212", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "54", "submission_status": "AP", "submission_status_date": "20190117", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "57248", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021536Orig1s054ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "57318", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s054lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "46", "submission_status": "AP", "submission_status_date": "20140304", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "60", "submission_status": "AP", "submission_status_date": "20220701", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "71508", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021536Orig1s060ltr.pdf", "date": "20220705", "type": "Letter" }, { "id": "71522", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s060lbl.pdf", "date": "20220706", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "44", "submission_status": "AP", "submission_status_date": "20130410", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "5676", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s044lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "15721", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021536Orig1s044ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "50", "submission_status": "AP", "submission_status_date": "20150123", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "37178", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021536Orig1s050ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "28056", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s050lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "28", "submission_status": "AP", "submission_status_date": "20121105", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "5671", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s028lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "15715", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536Orig1s028ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "24", "submission_status": "AP", "submission_status_date": "20090507", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "28051", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021172s044,021536s024ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "30", "submission_status": "AP", "submission_status_date": "20100122", "review_priority": "N/A", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "20080903", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "28049", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "57", "submission_status": "AP", "submission_status_date": "20191115", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "60899", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021536Orig1s057, s058ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "60904", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s057s058lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "47", "submission_status": "AP", "submission_status_date": "20140610", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "39", "submission_status": "AP", "submission_status_date": "20120427", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "5674", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536S039lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "15719", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s039ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "45", "submission_status": "AP", "submission_status_date": "20130215", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "37", "submission_status": "AP", "submission_status_date": "20120329", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "5673", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s037lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "15718", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s037ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "51", "submission_status": "AP", "submission_status_date": "20150225", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "57202", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021536Orig1s031,s051ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "5677", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021536Orig1s051.pdf", "date": "20200323", "type": "Review" }, { "id": "15722", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s031s051lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "29", "submission_status": "AP", "submission_status_date": "20120130", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "15716", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s029ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "28052", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s029lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "35", "submission_status": "AP", "submission_status_date": "20130309", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "5672", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s035lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "37177", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021536Orig1s035ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "41", "submission_status": "AP", "submission_status_date": "20120518", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "5675", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s041lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "15720", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021536s041ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "33", "submission_status": "AP", "submission_status_date": "20131031", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "15717", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021536Orig1s033ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "21724", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021536Orig1s033.pdf", "date": "20200323", "type": "Review" }, { "id": "28054", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536Orig1s033lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "31", "submission_status": "AP", "submission_status_date": "20150225", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "57201", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021536s031s051lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "28053", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021536Orig1s031,s051ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "37176", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021536Orig1s031.pdf", "date": "20200323", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "23", "submission_status": "AP", "submission_status_date": "20081128", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20050616", "review_priority": "STANDARD", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity", "application_docs": [ { "id": "5669", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021536ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "15713", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021-536_LevemirTOC.html", "date": "20200323", "type": "Review" }, { "id": "21722", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021536lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "15", "submission_status": "AP", "submission_status_date": "20070516", "review_priority": "N/A", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "5670", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021536Orig1s015.pdf", "date": "20200323", "type": "Review" }, { "id": "15714", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021536s015ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "21723", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021536s015lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "21", "submission_status": "AP", "submission_status_date": "20080903", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "28050", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "58", "submission_status": "AP", "submission_status_date": "20191115", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "60898", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s057s058lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "60905", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021536Orig1s057, s058ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "56", "submission_status": "AP", "submission_status_date": "20191227", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "61473", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s056lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "61596", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021536Orig1s056ltr.pdf", "date": "20200323", "type": "Letter" } ] } ], "application_number": "BLA021536", "sponsor_name": "NOVO NORDISK INC", "openfda": { "application_number": [ "BLA021536" ], "brand_name": [ "LEVEMIR" ], "generic_name": [ "INSULIN DETEMIR" ], "manufacturer_name": [ "Novo Nordisk" ], "product_ndc": [ "0169-3687", "0169-6438", "0169-6432" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INSULIN DETEMIR" ], "rxcui": [ "484322", "616238", "847239", "847241" ], "spl_id": [ "f474a2c6-c2fe-4dec-86a9-7fc2aef980f3" ], "spl_set_id": [ "d38d65c1-25bf-401d-9c7e-a2c3222da8af" ], "package_ndc": [ "0169-3687-12", "0169-3687-92", "0169-6438-10", "0169-6438-90", "0169-6438-97", "0169-6438-98", "0169-6432-55", "0169-6432-10" ], "nui": [ "N0000004931", "N0000175453" ], "pharm_class_cs": [ "Insulin [Chemical/Ingredient]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "4FT78T86XV" ] }, "products": [ { "product_number": "005", "reference_drug": "No", "brand_name": "LEVEMIR FLEXTOUCH", "active_ingredients": [ { "name": "INSULIN DETEMIR RECOMBINANT", "strength": "300 UNITS/3ML (100 UNITS/ML)" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "SUBCUTANEOUS", "marketing_status": "Prescription" }, { "product_number": "003", "reference_drug": "No", "brand_name": "LEVEMIR INNOLET", "active_ingredients": [ { "name": "INSULIN DETEMIR RECOMBINANT", "strength": "300 UNITS/3ML (100 UNITS/ML)" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "SUBCUTANEOUS", "marketing_status": "Discontinued" }, { "product_number": "001", "reference_drug": "No", "brand_name": "LEVEMIR", "active_ingredients": [ { "name": "INSULIN DETEMIR RECOMBINANT", "strength": "1000 UNITS/10ML (100 UNITS/ML)" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "SUBCUTANEOUS", "marketing_status": "Prescription" }, { "product_number": "004", "reference_drug": "No", "brand_name": "LEVEMIR PENFILL", "active_ingredients": [ { "name": "INSULIN DETEMIR RECOMBINANT", "strength": "300 UNITS/3ML (100 UNITS/ML)" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "SUBCUTANEOUS", "marketing_status": "Discontinued" }, { "product_number": "002", "reference_drug": "No", "brand_name": "LEVEMIR FLEXPEN", "active_ingredients": [ { "name": "INSULIN DETEMIR RECOMBINANT", "strength": "300 UNITS/3ML (100 UNITS/ML)" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "SUBCUTANEOUS", "marketing_status": "Discontinued" } ] } ] }