{ "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": "2026-07-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "14434760", "primarysourcecountry": "GB", "occurcountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20180711", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20180125", "receiptdateformat": "102", "receiptdate": "20180524", "fulfillexpeditecriteria": "1", "companynumb": "GB-BAXTER-2018BAX002547", "duplicate": "1", "reportduplicate": { "duplicatesource": "BAXTER", "duplicatenumb": "GB-BAXTER-2018BAX002547" }, "primarysource": { "reportercountry": "GB", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { 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"0641-6044-25", "0641-6046-01", "0641-6046-10", "0641-6045-01", "0641-6045-25", "0641-6047-01", "0641-6047-10", "72572-380-01", "72572-380-25", "69315-904-01", "69315-904-05", "69315-904-10", "69315-905-01", "69315-905-05", "69315-905-10", "69315-906-01", "69315-906-05", "69315-906-10", "0409-1539-03", "0409-1539-31", "0409-1985-03", "0409-1985-30", "63304-772-90", "63304-772-01", "63304-772-05", "63304-772-10", "63304-773-90", "63304-773-01", "63304-773-05", "63304-773-10", "63304-774-90", "63304-774-01", "63304-774-05", "63304-774-10", "0641-6003-01", "0641-6003-25", "0641-6002-01", "0641-6002-10", "0641-6001-01", "0641-6001-25", "0641-6000-01", "0641-6000-10" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "O26FZP769L" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ETOPOSIDE.", "drugstructuredosagenumb": "100", "drugstructuredosageunit": "009", "drugdosagetext": "ON DAY 1-3 OF EVERY 21-DAY CYCLE FOR 5 CYCLES", "drugadministrationroute": "042", "drugindication": "OSTEOSARCOMA RECURRENT", "drugstartdateformat": "102", "drugstartdate": "20170911", "drugenddateformat": "102", "drugenddate": "20171205", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "ETOPOSIDE" }, "openfda": { "application_number": [ "NDA019557", "ANDA074513", "ANDA074290", "NDA220200", "ANDA074529", "ANDA075635", "ANDA074983" ], "brand_name": [ "ETOPOSIDE", "AVOPEF", "VEPESID" ], "generic_name": [ "ETOPOSIDE" ], "manufacturer_name": [ "Onesource Specialty Pharma Limited", "Accord Healthcare Inc.", "Hikma Pharmaceuticals USA Inc.", "BluePoint Laboratories", "Avyxa Pharma, LLC", "Meitheal Pharmaceuticals Inc.", "Mylan Pharmaceuticals Inc.", "Amneal Pharmaceuticals NY LLC", "Fresenius Kabi USA, LLC" ], "product_ndc": [ "83270-451", "16729-114", "0143-9376", "68001-265", "0143-9510", "0143-9511", "0143-9512", "83831-144", "83831-145", "71288-175", "71288-176", "71288-177", "0378-3266", "68001-681", "68001-682", "68001-683", "69238-2811", "63323-104" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAVENOUS" ], "substance_name": [ "ETOPOSIDE" ], "rxcui": [ "197687", "310248", "2735802", "105592" ], "spl_id": [ "5744cb93-0a8c-19ca-e063-6294a90aecd6", "364ac37e-94f0-0dad-e063-6394a90aae33", "47d0c5ee-081e-44f7-9593-9888ae033165", "30d6f51a-8099-4ff9-9be6-fb0559c88e42", "15cf77cf-4207-463d-b6ef-16163db5afb9", "73ced17e-8a58-44b6-b901-347f1561f238", "737a9d5b-1260-408a-a117-b0b3aeba6ad4", "a591eea6-af04-4207-b0f7-61fbada4719c", "52475e80-bf46-f251-e063-6294a90a0e10", "254bddbd-10bf-4415-a1a1-bae57127edc5", "25cb14ea-3672-4f9a-9f4a-56052aec57ac" ], "spl_set_id": [ "7bc994df-ee84-4ed7-80fa-737f70918953", "4f850eb2-3542-43a0-90e8-bb37fa05cf15", "e0cd61b9-2375-4e3d-a610-d87dad962468", "157d4e0f-806d-4011-9dec-97e2449e507b", "6dfedeff-a807-4405-a482-2f7109ad31c9", "acc1e443-ef7b-486f-a638-710a20e81059", "50491106-dddd-4efd-bd83-060e7947a244", "508a418e-985f-4208-9324-2230655bb5c2", "0dddbe44-b4f4-431f-9011-8a54abbd4cbf", "2a40f3ed-4a36-4616-af6c-b616140fd5ee", "fe870629-104d-4d67-a7c6-f53bc588121e" ], "package_ndc": [ "83270-451-05", "16729-114-31", "16729-114-32", "16729-114-08", "16729-114-11", "0143-9376-01", "68001-265-22", "68001-265-25", "68001-265-23", "68001-265-26", "68001-265-24", "68001-265-27", "0143-9510-01", "0143-9511-01", "0143-9512-01", "83831-144-05", "83831-145-25", "71288-175-05", "71288-176-25", "71288-177-50", "0378-3266-94", "68001-681-25", "68001-682-26", "68001-683-27", "69238-2811-2", "63323-104-01", "63323-104-05", "63323-104-25", "63323-104-50", "63323-104-06" ], "nui": [ "N0000175609", "N0000000176" ], "pharm_class_epc": [ "Topoisomerase Inhibitor [EPC]" ], "pharm_class_moa": [ "Topoisomerase Inhibitors [MoA]" ], "unii": [ "6PLQ3CP4P3" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20171124" } } } ] }