{ "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. 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"drugcharacterization": "2", "medicinalproduct": "PROAIR HFA", "drugbatchnumb": "UNK", "drugindication": "ASTHMA", "actiondrug": "5", "activesubstance": { "activesubstancename": "ALBUTEROL SULFATE" } }, { "drugcharacterization": "2", "medicinalproduct": "SYMBICORT", "drugbatchnumb": "UNK", "drugindication": "ASTHMA", "drugstartdateformat": "102", "drugstartdate": "20150609", "actiondrug": "5", "activesubstance": { "activesubstancename": "BUDESONIDE\\FORMOTEROL FUMARATE DIHYDRATE" }, "openfda": { "application_number": [ "NDA021929" ], "brand_name": [ "SYMBICORT" ], "generic_name": [ "BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE" ], "manufacturer_name": [ "AstraZeneca Pharmaceuticals LP" ], "product_ndc": [ "0186-0370", "0186-0372" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "RESPIRATORY (INHALATION)" ], "substance_name": [ "BUDESONIDE", "FORMOTEROL FUMARATE" ], "rxcui": [ "1246288", "1246290", "1246304", "1246306", "1246314", "1246315", "1246316", "1246317" ], "spl_id": [ "1f05ded1-7d31-4cfc-8537-0e75f99ad452" ], "spl_set_id": [ "fafa4cf1-99c2-43d5-73ad-51f256de3be0" ], "package_ndc": [ "0186-0370-20", "0186-0370-28", "0186-0370-60", "0186-0372-20", "0186-0372-28", "0186-0372-60" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "W34SHF8J2K", "Q3OKS62Q6X" ] } }, { "drugcharacterization": "1", "medicinalproduct": "DUPILUMAB", "drugbatchnumb": "UNK", "drugdosagetext": "BLINDED THERAPY, WEEKLY", "drugadministrationroute": "058", "drugindication": "DERMATITIS ATOPIC", "drugstartdateformat": "102", "drugstartdate": "20150506", "actiondrug": "5", "activesubstance": { "activesubstancename": "DUPILUMAB" }, "openfda": { "application_number": [ "BLA761055" ], "brand_name": [ "DUPIXENT" ], "generic_name": [ "DUPILUMAB" ], "manufacturer_name": [ "Sanofi-Aventis U.S. LLC" ], "product_ndc": [ "0024-5914", "0024-5918", "0024-5915", "0024-5919" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "DUPILUMAB" ], "rxcui": [ "1876401", "1876406", "2099300", "2099302", "2375327", "2375329", "2559706", "2559707" ], "spl_id": [ "06b9c64b-52b1-490b-b118-bd079e69264e" ], "spl_set_id": [ "595f437d-2729-40bb-9c62-c8ece1f82780" ], "package_ndc": [ "0024-5914-00", "0024-5914-01", "0024-5914-20", "0024-5914-02", "0024-5918-00", "0024-5918-01", "0024-5918-20", "0024-5918-02", "0024-5915-00", "0024-5915-02", "0024-5915-01", "0024-5915-20", "0024-5919-00", "0024-5919-02", "0024-5919-01", "0024-5919-20" ], "nui": [ "N0000193342", "N0000193341", "M0001357" ], "pharm_class_epc": [ "Interleukin-4 Receptor alpha Antagonist [EPC]" ], "pharm_class_moa": [ "Interleukin 4 Receptor alpha Antagonists [MoA]" ], "pharm_class_cs": [ "Antibodies, Monoclonal [CS]" ], "unii": [ "420K487FSG" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20150806" } } } ] }