{ "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": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20171020", "review_priority": "STANDARD", "submission_class_code": "TYPE 3", "submission_class_code_description": "Type 3 - New Dosage Form", "application_docs": [ { "id": "50156", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209210s000lbl.pdf", "date": "20171024", "type": "Label" }, { "id": "50488", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209210Orig1s000ltr.pdf", "date": "20171127", "type": "Letter" }, { "id": "55864", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209210Orig1s000TOC.html", "date": "20181010", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "20190725", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "59460", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf", "date": "20190726", "type": "Letter" }, { "id": "59507", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf", "date": "20190730", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "5", "submission_status": "AP", "submission_status_date": "20190725", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "59458", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf", "date": "20190726", "type": "Letter" }, { "id": "59509", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf", "date": "20190730", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "20220726", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "71640", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209210Orig1s019ltr.pdf", "date": "20220727", "type": "Letter" }, { "id": "71645", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s019lbl.pdf", "date": "20220727", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "25", "submission_status": "AP", "submission_status_date": "20250528", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "82349", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209210Orig1s025ltr.pdf", "date": "20250529", "type": "Letter" }, { "id": "82386", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209210s025lbl.pdf", "date": "20250602", "type": "Label" }, { "id": "82387", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209210s025lbl.pdf#page=37", "date": "20250602", "type": "Medication Guide" } ] }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "20190725", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "59456", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf", "date": "20190726", "type": "Letter" }, { "id": "59511", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf", "date": "20190730", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "20210722", "review_priority": "PRIORITY", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "68165", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209210s017lbl.pdf", "date": "20210723", "type": "Label" }, { "id": "68179", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209210Orig1s017ltr.pdf", "date": "20210726", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20190215", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "57708", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s001lbl.pdf", "date": "20190220", "type": "Label" }, { "id": "57724", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s001ltr.pdf", "date": "20190221", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "23", "submission_status": "AP", "submission_status_date": "20240306", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "77748", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209210s023lbl.pdf", "date": "20240307", "type": "Label" }, { "id": "77781", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209210Orig1s023ltr.pdf", "date": "20240312", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "21", "submission_status": "AP", "submission_status_date": "20220610", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "71303", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209210Orig1s021ltr.pdf", "date": "20220614", "type": "Letter" }, { "id": "71320", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s021lbl.pdf", "date": "20220615", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "11", "submission_status": "AP", "submission_status_date": "20200228", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "62006", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209210s011lbl.pdf", "date": "20200302", "type": "Label" }, { "id": "62016", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209210Orig1s011ltr.pdf", "date": "20200303", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "20190725", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "59461", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf", "date": "20190726", "type": "Letter" }, { "id": "59505", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf", "date": "20190730", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "6", "submission_status": "AP", "submission_status_date": "20190725", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "59459", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf", "date": "20190726", "type": "Letter" }, { "id": "59508", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf", "date": "20190730", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "20190725", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "59457", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf", "date": "20190726", "type": "Letter" }, { "id": "59510", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf", "date": "20190730", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "20190725", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "59455", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209210Orig1s002,s003,s004,s005,s006,s007,s008ltr.pdf", "date": "20190726", "type": "Letter" }, { "id": "59512", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf", "date": "20190730", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "24", "submission_status": "AP", "submission_status_date": "20241101", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "80107", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209210s024lbl.pdf", "date": "20241104", "type": "Label" }, { "id": "80108", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209210s024lbl.pdf#page=37", "date": "20241104", "type": "Medication Guide" }, { "id": "80126", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209210Orig1s024ltr.pdf", "date": "20241105", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "22", "submission_status": "AP", "submission_status_date": "20221221", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "72998", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209210Orig1s022ltr.pdf", "date": "20221222", "type": "Letter" }, { "id": "73011", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s022lbl.pdf", "date": "20221223", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "20201202", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "65476", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209210s014lbl.pdf", "date": "20201202", "type": "Label" }, { "id": "65493", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209210Orig1s014ltr.pdf", "date": "20201203", "type": "Letter" } ] } ], "application_number": "NDA209210", "sponsor_name": "ASTRAZENECA AB", "products": [ { "product_number": "001", "reference_drug": "Yes", "brand_name": "BYDUREON BCISE", "active_ingredients": [ { "name": "EXENATIDE SYNTHETIC", "strength": "2MG/0.85ML (2MG/0.85ML)" } ], "reference_standard": "No", "dosage_form": "SUSPENSION, EXTENDED RELEASE", "route": "SUBCUTANEOUS", "marketing_status": "Discontinued" } ] } ] }