{ "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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"drugstartdateformat": "102", "drugstartdate": "20140110", "drugenddateformat": "102", "drugenddate": "20140225", "actiondrug": "1", "activesubstance": { "activesubstancename": "TELAPREVIR" } }, { "drugcharacterization": "2", "medicinalproduct": "COPEGUS", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20131206", "drugenddateformat": "102", "drugenddate": "20140225", "activesubstance": { "activesubstancename": "RIBAVIRIN" } }, { "drugcharacterization": "2", "medicinalproduct": "SUBOXONE", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "602", "drugstartdate": "2012", "activesubstance": { "activesubstancename": "BUPRENORPHINE HYDROCHLORIDE\\NALOXONE HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA022410" ], "brand_name": [ "SUBOXONE" ], "generic_name": [ "BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE" ], "manufacturer_name": [ "INDIVIOR INC." ], "product_ndc": [ "12496-1202", "12496-1204", "12496-1208", "12496-1212" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "BUCCAL", "SUBLINGUAL" ], "substance_name": [ "BUPRENORPHINE HYDROCHLORIDE", "NALOXONE HYDROCHLORIDE" ], "rxcui": [ "1010600", "1010603", "1010604", "1010606", "1307056", "1307058", "1307061", "1307063" ], "spl_id": [ "ad5a289a-6285-4b2d-b7ad-e4812169dd58" ], "spl_set_id": [ "8a5edcf9-828c-4f97-b671-268ab13a8ecd" ], "package_ndc": [ "12496-1202-1", "12496-1202-3", "12496-1204-1", "12496-1204-3", "12496-1208-1", "12496-1208-3", "12496-1212-1", "12496-1212-3" ], "unii": [ "56W8MW3EN1", "F850569PQR" ] } }, { "drugcharacterization": "1", "medicinalproduct": "DEPAKINE CHRONO", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "018081", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "002", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "EXTENDED RELEASE TABLET", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20131001", "actiondrug": "4", "activesubstance": { "activesubstancename": "VALPROATE SODIUM" } }, { "drugcharacterization": "3", "medicinalproduct": "ZYPREXA", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosageform": "COATED TABLET", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20131001", "actiondrug": "4", "activesubstance": { "activesubstancename": "OLANZAPINE" }, "openfda": { "application_number": [ "NDA020592", "NDA021253", "NDA021086", "NDA022173" ], "brand_name": [ "ZYPREXA", "ZYPREXA INTRAMUSCULAR", "ZYPREXA ZYDIS", "ZYPREXA RELPREVV" ], "generic_name": [ "OLANZAPINE", "OLANZAPINE PAMOATE" ], "manufacturer_name": [ "H2-Pharma LLC" ], "product_ndc": [ "61269-630", "61269-631", "61269-632", "61269-633", "61269-634", "61269-635", "61269-650", "61269-651", "61269-652", "61269-653", "61269-640", "61269-660", "61269-661", "61269-662" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR" ], "substance_name": [ "OLANZAPINE" ], "rxcui": [ "153046", "153047", "153048", "200034", "212405", "261337", "283639", "284514", "312076", "312077", "312078", "312079", "314154", "314155", "351107", "351108", "485968", "545353", "754503", "754504", "754505", "754506", "1718925", "1718928", "1718930", "1718932", "1718934", "1718936" ], "spl_id": [ "40d4ed67-c51d-40d0-8a32-ecfdbf069f9a", "9c56e9db-742e-4263-96b4-d92064f9baba" ], "spl_set_id": [ "b418946a-1ab4-4d89-a012-d94fc361a3c4", "11544cba-64a9-49cb-8d74-da228053b252" ], "package_ndc": [ "61269-630-30", "61269-631-30", "61269-632-30", "61269-633-30", "61269-634-30", "61269-635-30", "61269-650-01", "61269-650-35", "61269-651-01", "61269-651-35", "61269-652-01", "61269-652-35", "61269-653-01", "61269-653-35", "61269-640-20", "61269-660-20", "61269-661-20", "61269-662-20" ], "nui": [ "N0000175430" ], "pharm_class_epc": [ "Atypical Antipsychotic [EPC]" ], "unii": [ "N7U69T4SZR" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140224" } } }, { "safetyreportversion": "2", "safetyreportid": "10004909", "primarysourcecountry": "JP", "occurcountry": "JP", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "PHHY2013JP077325", "duplicate": "1", "reportduplicate": { "duplicatesource": "NOVARTIS", "duplicatenumb": "PHHY2013JP077325" }, "primarysource": { "reportercountry": "JP", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "36", "patientonsetageunit": "801", "patientweight": "80", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Weight decreased", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Subileus", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Sedation", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Somnolence", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Constipation", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Akathisia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Abnormal behaviour", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "12.5", "drugstructuredosageunit": "003", "drugdosagetext": "12.5 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "SCHIZOPHRENIA, PARANOID TYPE", "drugstartdateformat": "102", "drugstartdate": "20110510", "drugenddateformat": "102", "drugenddate": "20110512", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "drugdosagetext": "25 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110513", "drugenddateformat": "102", "drugenddate": "20110516", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugdosagetext": "50 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110517", "drugenddateformat": "102", "drugenddate": "20110520", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "75", "drugstructuredosageunit": "003", "drugdosagetext": "75 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110521", "drugenddateformat": "102", "drugenddate": "20110523", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "100", "drugstructuredosageunit": "003", "drugdosagetext": "100 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110524", "drugenddateformat": "102", "drugenddate": "20110525", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "125", "drugstructuredosageunit": "003", "drugdosagetext": "125 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110526", "drugenddateformat": "102", "drugenddate": "20110528", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "150", "drugstructuredosageunit": "003", "drugdosagetext": "150 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110529", "drugenddateformat": "102", "drugenddate": "20110530", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "175", "drugstructuredosageunit": "003", "drugdosagetext": "175 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110531", "drugenddateformat": "102", "drugenddate": "20110603", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "200", "drugstructuredosageunit": "003", "drugdosagetext": "200 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110604", "drugenddateformat": "102", "drugenddate": "20110613", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "250", "drugstructuredosageunit": "003", "drugdosagetext": "250 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110614", "drugenddateformat": "102", "drugenddate": "20110620", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugdosagetext": "300 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110621", "drugenddateformat": "102", "drugenddate": "20110627", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "350", "drugstructuredosageunit": "003", "drugdosagetext": "350 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110628", "drugenddateformat": "102", "drugenddate": "20110704", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "400", "drugstructuredosageunit": "003", "drugdosagetext": "400 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110705", "drugenddateformat": "102", "drugenddate": "20110711", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": 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"drugenddateformat": "102", "drugenddate": "20110808", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "600", "drugstructuredosageunit": "003", "drugdosagetext": "600 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110809", "drugenddateformat": "102", "drugenddate": "20110819", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "400", "drugstructuredosageunit": "003", "drugdosagetext": "400 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20110920", "drugenddateformat": "102", "drugenddate": "20120701", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "425", "drugstructuredosageunit": "003", "drugdosagetext": "425 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20120702", "drugenddateformat": "102", "drugenddate": "20121028", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "400", "drugstructuredosageunit": "003", "drugdosagetext": "400 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20121029", "drugenddateformat": "102", "drugenddate": "20130120", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "CLOZARIL (CLOZAPINE)", "drugstructuredosagenumb": "375", "drugstructuredosageunit": "003", "drugdosagetext": "375 MG, UNK", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20130121", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "RISPERIDONE", "drugauthorizationnumb": "78528", 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Perrigo Company", "Spirit Pharmaceutical LLC", "Meijer, Inc.", "TWIN MED LLC", "Better Living Brands, LLC", "Wal-Mart Stores, Inc.", "Haleon US Holdings LLC", "SAM'S WEST INC", "Dr. Reddy's Laboratories Limited", "Unifirst First Aid Corporation", "Chartwell RX, LLC", "CVS Pharmacy", "TIME CAP LABORATORIES,INC", "Kenvue Brands LLC", "Aurohealth LLC", "AptaPharma Inc.", "Chain Drug Marketing Association Inc.", "Uline", "Breeden Brothers, LLC", "FSA STORE INC.", "Amerisource Bergen", "Target Corporation", "Shield Pharmaceuticals Corp", "CVS", "Amazon.com Services LLC", "Advagen Pharma Ltd.", "WALGREEN COMPANY", "Cintas Corporation", "Sun Pharmaceutical Industries, Inc.", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "Mollec Inc", "INGLES MARKETS, INC.", "BJWC", "Strides Pharma Inc.", "Pioneer Life Sciences, LLC", "Wal-Mart Stores Inc", "Strategic Sourcing Services LLC", "Bionpharma Inc.", "Grocery Outlet, Inc.", "Randob Labs., Ltd.", "CHAIN DRUG MARKETING ASSOCIATION INC.", "Amneal Pharmaceuticals of New York LLC", "Winco Foods, LLC", "Walgreens", "Pharmadel LLC", "RETAIL BUSINESS SERVICES , LLC.", "PureTek Corporation", "CHAIN DRUG MARKETING ASSOCIATION INC", "Lil Drug Store Products, Inc", "H E B", "Live Betr LLC", "Softgel Healthcare Private Limited", "United Natural Foods, Inc. dba UNFI", "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "Granules India Limited", "Guardian Drug Company", "WINCO FOODS, LLC", "NorthStar Rx LLC", "Major Pharmaceuticals", "Topco Associates LLC", "Dolgencorp, LLC", "Allegiant Health", "Walgreen Company", "Care One (American Sales Company)", "L.N.K. International, Inc.", "Retail Business Services, LLC", "Geri-Care Pharmaceutical Corp", "Dolgencorp Inc", "Cumberland Pharmaceuticals Inc.", "Family Dollar (FAMILY WELLNESS)", "Westminster Pharmaceuticals, LLC", "Chain Drug Marketing Association, Inc.", "VALU MERCHANDISERS COMPANY", "TIME CAP LABORATORIES, INC.", "FSA Store Inc. (Caring Mills)", "Spirit Pharmaceuticals LLC", "WR Group, Inc.", "BETTER LIVING BRANDS, LLC", "Rugby Laboratories, Inc.", "HART Health", "Henry Schein Inc.", "MARKSANS PHARMA LIMITED", "Topco Associates, LLC", "WALGREENS", "Publix Super Markets Inc", "SOLA Pharmaceuticals, LLC", "Meijer Distribution Inc", "Best Choice (Valu Merchandisers Company)", "TOPCO ASSOCIATES LLC", "Trifecta Pharmaceuticals USA LLC", "AMERISOURCE BERGEN", "RITE AID", "PAI Holdings, LLC dba PAI Pharma", "TOP CARE (Topco Associates LLC)", "Marc Glassman, Inc.", "Chain Drug Consortium", "RITE AID CORPORATION", "HEB", "Amneal Pharmaceuticals LLC", "Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd", "Pharmaceutical Associates, Inc.", "Amneal Pharmaceuticals NY LLC", "KROGER COMPANY", "Lil' Drug Store Products, Inc.", "PURACAP PHARMACEUTICAL LLC", "Thompson Safety", "FSA Store Inc. (Caring Mill)", "PLD Acquisitions LLC DBA Avma Pharma Solutions", "Cardinal Health 110, LLC. DBA Leader", "Lidl US LLC", "BluePoint Laboratories", "WALMART INC.", "BETTER LIVING BRANDS LLC.", "Sam's West, Inc", "MARC GLASSMAN, INC.", "Strides Pharma Inc", "Chalkboard Health", "TIME CAP LABORATORIES, INC", "Family Dollar Services, Inc.", "BJWC (Berkley & Jensen / BJ's)", "Costco Wholesale Company", "Safeway", "RETAIL BUSINESS SERVICES,LLC.", "Discount Drug Mart", "Basic Drugs, Inc.", "Padagis Israel Pharmaceuticals Ltd", "Strides Pharma Science Limited", "AiPing Pharmaceutical, Inc.", "DEMOULAS SUPERMARKETS INC.", "ARMY AND AIR FORCE EXCHANGE SERVICE", "Belmora LLC", "The Kroger Co.", "WALGREEN CO.", "Puro Pharma Inc.", "Aurobindo Pharma Limited", "Melaleuca, Inc", "Costco Wholesale", "P & L Development, LLC", "Albertsons Companies", "Discount Drug Mart, Inc", "PROSTAT FIRST AID", "Wildman Business Group", "Unishield", "MEIJER DISTRIBUTION INC.", "Granules Pharmaceuticals Inc.", "TARGET CORPORATION", "Ascend Laboratories, LLC", "Safeway, Inc.", "CVS Pharmacy. Inc.", "Chain Drug Consortium, LLC", "JHK Inc dba American Safety & First Aid", "Harris Teeter, LLC", "Demoulas Super Markets, Inc", "ADVANCED FIRST AID, INC.", "Sam's West Inc", "Family Dollar Services Inc", "DISCOUNT DRUG MART", "Unifirst First Aid", "RANDOB LABS,LTD. 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