{
  "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
    }
  },
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    {
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      "primarysourcecountry": "US",
      "occurcountry": "US",
      "transmissiondateformat": "102",
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      "reporttype": "1",
      "serious": "2",
      "receivedateformat": "102",
      "receivedate": "20230823",
      "receiptdateformat": "102",
      "receiptdate": "20231117",
      "fulfillexpeditecriteria": "2",
      "companynumb": "US-Stemline Therapeutics, Inc.-2023ST001528",
      "primarysource": {
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        "qualification": "5"
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      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
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      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
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      "patient": {
        "patientonsetage": "87",
        "patientonsetageunit": "801",
        "patientagegroup": "6",
        "patientsex": "2",
        "reaction": [
          {
            "reactionmeddraversionpt": "26.1",
            "reactionmeddrapt": "Urine odour abnormal",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "26.1",
            "reactionmeddrapt": "Burning sensation",
            "reactionoutcome": "2"
          },
          {
            "reactionmeddraversionpt": "26.1",
            "reactionmeddrapt": "Pruritus",
            "reactionoutcome": "2"
          },
          {
            "reactionmeddraversionpt": "26.1",
            "reactionmeddrapt": "Dry mouth",
            "reactionoutcome": "2"
          },
          {
            "reactionmeddraversionpt": "26.1",
            "reactionmeddrapt": "Erythema",
            "reactionoutcome": "2"
          },
          {
            "reactionmeddraversionpt": "26.1",
            "reactionmeddrapt": "Facial pain",
            "reactionoutcome": "2"
          },
          {
            "reactionmeddraversionpt": "26.1",
            "reactionmeddrapt": "Urinary tract infection",
            "reactionoutcome": "2"
          },
          {
            "reactionmeddraversionpt": "26.1",
            "reactionmeddrapt": "Abdominal pain upper",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "26.1",
            "reactionmeddrapt": "Rash",
            "reactionoutcome": "2"
          },
          {
            "reactionmeddraversionpt": "26.1",
            "reactionmeddrapt": "Dizziness",
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          {
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              "manufacturer_name": [
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          {
            "drugcharacterization": "2",
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                "CORTISONE 10 SENSITIVE SKIN CREME",
                "WALGREENS SCALP RELIEF EXTERNAL ANALGESIC",
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                "TOPCARE HYDROCORTISONE",
                "ANTI ITCH",
                "CORTIZONE 10 WATER RESISTANT",
                "VIADERMA CALM ANTI-ITCH",
                "POST TREATMENT BALM",
                "HYDROCORTISONE PLUS 12 MOISTURIZERS",
                "FIFTHPULSE HYDROCORTISONE 1OZ",
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                "BARMICIL ANTI-ITCH",
                "HERB STREET ANTI-ITCH STICK",
                "THERA PLUS HYDROCORTISONE MAXIMUM STRENGTH",
                "CORTISONE 10 INTENSIVE MOISTURE CREME",
                "CORTIZONE 10 SOOTHING ALOE ITCH RELIEF",
                "EXCHANGE SELECT HYDROCORTISONE",
                "CARE ONE HYDROCORTISONE MAXIMUM STRENGTH",
                "REXALL ANTI ITCH MAXIMUM STRENGTH RELIEF",
                "AVON HEXASHIELD ANTI ITCH CREAM WITH HEALING ALOE",
                "CARING MILLS HYDROCORTISONE",
                "GELMICIN HYDROCORTISONE WITH ALOE",
                "GREEN GUARD HYDROCORTISONE 1%",
                "CAREALL HYDROCORTISONE MAXIMUM STRENGTH",
                "EQUALINE ANTI ITCH",
                "BLOOP ITCH SOOTHING TOPICAL",
                "BERKLEY AND JENSEN ANTI ITCH",
                "ASTONEA",
                "SIGNATURE CARE ANTI ITCH",
                "CORTISONE 10 OVERNIGHT CREME",
                "CORTIZONE 10 FAST ACTING ITCH RELIEF COOLING",
                "DRS. HYDROCORTISONE ALOE VERA",
                "THERA PLUS MAXIMUM STRENGTH HYDROCORTISONE",
                "BASIC CARE HYDROCORTISONE",
                "THERA PLUS",
                "GOOD NEIGHBOR PHARMACY HYDROCORTISONE WITH ALOE FOR SENSITIVE SKIN",
                "FAMILY WELLNESS",
                "HYDROCORTISONE 1",
                "HYDROCORTISONE WITH ALOE",
                "SIGNATURE CARE HYDROCORTISONE",
                "MAXIMUM STRENGTH HYDROCORTISONE",
                "MEMBERS MARK HYDROCORTISONE",
                "MEDPRIDE",
                "INSTANT COOLING ITCH RELIEF",
                "HYDROXYM",
                "ANTI-ITCH PARABEN FREE",
                "AVEDANA HYDROCORTISONE CREAM WITH ALOE",
                "HYDROCORTISONE CREAM",
                "HYDROCORTISONE ANTI ITCH",
                "ASSURED",
                "BARMICIL PLUS",
                "EQUATE HYDROCORTISONE",
                "MONISTAT COMPLETE CARE INSTANT ITCH RELIEF",
                "SKIN RELIEF CREAM",
                "RAPIDOL",
                "ALKINDI SPRINKLE",
                "PUBLIX HYDRO",
                "PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE",
                "QUALITY CHOICE",
                "PROCURE HYDROCORTISONE 1%",
                "SKIN A COOL HYDROCORTISONE ANTI-ITCH",
                "CVS CORTISONE LIQUID",
                "CAREONE ANTI ITCH",
                "CVS ANTI ITCH",
                "CORTISONE",
                "EQUALINE ANTI ITCH MAXIMUM STRENGTH",
                "CVS COOLS ITCH FAST",
                "QUADRYDERN",
                "KERA HC",
                "WINCO MAXIMUM STRENGTH HYDROCORTISONE",
                "ABSOLUT SKIN CORTICOSOOTHE ANTI-ITCH",
                "THOMPSON HYDROCORTISONE 1%",
                "LIVE BETTER HYDROCORTISONE WITH ALOE",
                "WALGREENS SCALP ITCH RELIEF",
                "FIXMYSKIN HEALING BALM VANILLA FLAVOR",
                "LYEON ANTI-ITCH CREAM",
                "GOOD SENSE ANTI ITCH",
                "CORTIZONE 10 EASY RELIEF",
                "AUDIOLOGIST ANTI-ITCH",
                "CORTENEMA",
                "FREDS HYDROCORTISONE WITH ALOE",
                "HYDROCORTISONE CREAM WITH ALOE",
                "ITCH AND RASH CREAM",
                "TOTAL RELIEF",
                "CORTISOL PHENOLIC",
                "DR. SHEFFIELD HYDROCORTISONE ANTI ITCH",
                "PEDIADERMICS ECZEMA 2",
                "HYDROCORTISONE 1% ANTI-ITCH CREAM",
                "DG HEALTH HYDROCORTISONE MAXIMUM STRENGTH",
                "CORTISOL",
                "DIPROSPAN",
                "HEXASHIELD ANTI ITCH CREAM WITH HEALING ALOE",
                "FIXMYSKIN HEALING BALM FRAGRANCE-FREE",
                "THERACARE HYDROCORTISONE CREAM",
                "TERRAMED JUST THINK COMFORT HYDROCORTISONE 1% CREAM",
                "KHINDIVI",
                "MAXIMUM STRENGTH SCALP ITCH RELIEF ANTI-ITCH",
                "EQUATE HYDROCORTISONE INTENSIVE HEALING FORMULA",
                "CVS CORTISONE",
                "ANTI-ITCH REGULAR STRENGTH",
                "ITCH RELIEF",
                "CORTIZONE 10 INTENSIVE HEALING",
                "CORTIZONE 10 COOLING RELIEF",
                "CORTIZONE 10",
                "CORTIZONE 10 INTENSIVE HEALING ITCH RELIEF CREAM",
                "NIZORAL SCALP ITCH RELIEF",
                "HYDROCORTISONE ANTI-ITCH",
                "AVEENO HYDROCORTISONE ANTI-ITCH",
                "GOOD NEIGHBOR PHARMACY HYDROCORTISONE PLUS 12 MOISTURIZERS",
                "AEROSOOTHE",
                "INTENSIVE HEALING ECZEMA",
                "CORTIZONE 10 ULTRA SOOTHING ITCH RELIEF",
                "CRANE SAFETY HYDROCORTISONE",
                "FIXMYSKIN HEALING BALM UNFLAVORED",
                "PREPARATION H HYDROCORTISONE",
                "FAMILY WELLNESS MAX STRENGTH 1 HYDROCORTISONE CREAM",
                "THERAPLEX AIM ANTI-ITCH MOISTURIZING",
                "AOSI HEALTHCARE",
                "HEALING TREE CALMING ANTI-ITCH",
                "PROCURE HYDROCORTISONE CREAM PLUS",
                "GERIGENTLE",
                "AVEENO 1% HYDROCORTISONE ANTI-ITCH CREAM",
                "TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA",
                "FAMILY CARE ANTI-ITCH",
                "CORTIZONE 10 ITCH RELIEF MASSAGING ROLLERBALL",
                "FIFTHPULSE HYDROCORTISONE 4OZ",
                "UNISHIELD 1%",
                "ALA-SCALP",
                "QUATRIDERM ANTI-ITCH",
                "ELIXIRCORTIRELIEF",
                "WINCO FOODS HYDROCORTISONE CREAM INTENSIVE HEALING",
                "HEALTH BEYOND",
                "CORTIZONE-10 SOOTHING ALOE CREME",
                "ALOE CORT",
                "CORTEF",
                "CORTIZONE 10 FEMININE ITCH RELIEF",
                "FIFTHPULSE HYDROCORTISONE",
                "TEXACORT",
                "CORTIZONE 10 INTENSIVE HEALING FOR ECZEMA",
                "CVS HEALTH HYDROCORTISONE ANTI ITCH",
                "FREDS HYDROCORTISONE PLUS 12 MOISTURIZERS",
                "DISCOUNT DRUG MART ANTI-ITCH",
                "WESTLAKE ANTI-ITCH",
                "HYDROCORTISONE 1% WITH HEALING ALOE",
                "SHOPKO HYDROCORTISONE",
                "TRUELIPIDS 1% HYDROCORTISONE BARRIER CREAM",
                "EQUATE HYDROCORTISONE TOPICAL",
                "DERMACORT ANTI-ITCH",
                "NATUREPLEX HYDROCORTISONE HYDRO",
                "GEMBOOXT ECZEMA RELIEF CREAM",
                "QUADRIDERM NF",
                "ANA COOL RAPID SOOTHING COOLING FORMULA",
                "SCALPICIN ANTI-ITCH MAXIMUM STRENGTH",
                "AQUAPHOR ITCH RELIEF",
                "TOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS",
                "DERMAREST ECZEMA MEDICATED",
                "POST-TREATMENT REPAIR CREAM",
                "CLINICALM",
                "SUNMARK HYDROCORTISONE",
                "POST TREATMENT REPAIR CREAM",
                "HYDROCORTISONE INTENSIVE HEALING FORMULA",
                "THERA PLUS ANTI-ITCH WITH ALOE HYDROCORTISONE",
                "ALACORT",
                "PROCTO-MED HC",
                "HYDROCORTISONE RECTAL SUSPENSION (RETENTION)",
                "KIRKLAND SIGNATURE HYDROCORTISONE PLUS MAXIMUM STRENGTH",
                "CORTIZONE 10 ULTRA SOOTHING CREME",
                "JJ CARE",
                "SURVIVEX HYDROCORTISONE CREAM",
                "XPECT HYDROCORTISONE",
                "ANUSOL HC",
                "THERA PLUS ECZEMA HYDROCORTISONE ANTI ITCH",
                "PREPARATION H SOOTHING RELIEF ANTI-ITCH",
                "ALUMIER MD INTENSIVE RECOVERY",
                "VANICREAM HC ANTI-ITCH",
                "CVS NO MESS CORTISONE",
                "PETROCORT ANTIPRURITIC LIP 21",
                "CERAVE DEVELOPED WITH DERMATOLOGISTS ANTI ITCH",
                "CVS HEALTH MAXIMUM STRENGTH SCALP RELIEF ANTI-ITCH",
                "NO MESS HYDROCORTISONE APPLICATOR",
                "GOOD NEIGHBOR PHARMACY HYDROCORTISONE WITH ALOE",
                "CORTIZONE 10 COOLING",
                "HYDROCORTISONE ANTI-ITCH PLUS",
                "ANTI-ITCH"
              ],
              "generic_name": [
                "HYDROCORTISONE",
                "ANTIPRURITIC (ANTI-ITCH)",
                "ANTI-ITCH CREAM",
                "HYDROCORTISONE CREAM",
                "HYDROCORTISONE 1%",
                "HYDROCORTISONE CREAM 1%",
                "HYDROCORTISONE CREAM 1/2%",
                "ANTI-PRURITIC",
                "HYDROCORTISONE CONTINUOUS SPRAY",
                "HYDROCORTISONE LOTION",
                "HYDROCORTISONE ACETATE",
                "ANTI-ITCH",
                "COOL RELIEF GEL WITH ALOE",
                "HYDROCORTISONE SPRAY",
                "DRS. HYDROCORTISONE"
              ],
              "manufacturer_name": [
                "TRIFECTA PHARMACEUTICALS USA LLC",
                "Dolgencorp, LLC",
                "Rite Aid Corporation",
                "BalmRx, LLC",
                "Unifirst First Aid Corporation",
                "HARRIS TEETER LLC",
                "Sun Pharmaceutical Industries, Inc.",
                "AmerisourceBergen",
                "Publix Super Markets Inc",
                "Chattem, Inc.",
                "Walgreen Company",
                "Shopko Stores Operating Co., LLC",
                "Nantong Health & Beyond Hygienic Products Inc.",
                "LEADER",
                "The Kroger Co",
                "ProStat First Aid",
                "BluePoint Laboratories",
                "Topco Associates LLC",
                "Strides Pharma Inc.",
                "Redmont Pharmaceuticals, LLC",
                "Safeway",
                "Padagis Israel Pharmaceuticals Ltd",
                "Meijer, Inc.",
                "VIADERMA DISTRIBUTION INC",
                "Allure Labs Inc.",
                "RITE AID CORPORATION",
                "Front Pharmaceutical PLC",
                "Chartwell RX, LLC.",
                "Person and Covey",
                "OPMX LLC",
                "Balassa Laboratories Inc.",
                "HyVee Inc",
                "FOURSTAR GROUP USA, INC.",
                "Army & Air Force Exchange Service",
                "American Sales Company",
                "Tai Guk Pharm. Co., Ltd.",
                "Veridian Healthcare",
                "United Exchange Corp.",
                "New World Imports, Inc",
                "United Natural Foods, Inc. dba UNFI",
                "Three Nations Corp",
                "BJWC",
                "ASTONEA LABS PRIVATE LIMITED",
                "Geri-Care Pharmaceuticals, Corp",
                "OL PHARMA TECH,LLC",
                "Water-Jel Technologies",
                "Fourstar Group USA, Inc",
                "Amazon.com Services LLC",
                "Encube Ethicals, Inc.",
                "Trifecta Pharmaceuticals Usa Llc",
                "Zhejiang Jingwei Pharmaceutical Co., Ltd.",
                "HART Health",
                "Kroger Company",
                "TARGET Corporation",
                "Pharmacy Value Alliance LLC",
                "DLC Laboratories, Inc",
                "Sam's West Inc",
                "VIVE HEALTH LLC",
                "Shield Line LLC",
                "CVS Pharmacy",
                "Aurobindo Pharma Limited",
                "Eywa Pharma Inc",
                "AKRON PHARMA INC",
                "PureTek Corporation",
                "Weeks & Leo Co., Inc.",
                "H E B",
                "Unipack LLC",
                "Trifecta Pharmaceuticals USA",
                "Crown Laboratories",
                "Zhejiang Jingwei Pharmaceutic Al Co., Ltd.",
                "ANI Pharmaceuticals, Inc.",
                "ALLIED TRADE LINK LLC",
                "Aldermed Inc.",
                "Wal-Mart Stores Inc",
                "Insight Pharmaceuticals LLC",
                "Henry Schein",
                "Spa de Soleil",
                "Pharmadel LLC",
                "Eton Pharmaceuticals, Inc.",
                "Click Industries LLC",
                "Chartwell RX, LLC",
                "Amneal Pharmaceuticals of New York LLC",
                "Chain Drug Marketing Association Inc.",
                "Chain Drug Marketing Association, Inc.",
                "Twin Med LLC",
                "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc",
                "Ana-Cool, LLC",
                "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
                "CVS",
                "Strides Pharma Science Limited",
                "CVS Pharmacy, Inc.",
                "Productos Zapotol Corp",
                "Clinical Therapeutic Solutions",
                "WINCO FOODS, LLC",
                "Absolut Skin Incorporated",
                "Thompson",
                "The Great Atlantic & Pacific Tea Company",
                "Walgreens",
                "Lovely Skin, Inc.",
                "Guangzhou Xinhongda Trading Service Co., Ltd.",
                "L. Perrigo Company",
                "WalMart",
                "OAKTREE PRODUCTS, INC.",
                "FRED'S, INC.",
                "Cardinal Health 110 dba LEADER",
                "Wildman Business Group",
                "DR. MARDER SKINCARE, LLC",
                "Energique, Inc.",
                "Sheffield Pharmaceuticals LLC",
                "Cardinal Health",
                "RENU LABORATORIES, LLC",
                "DLC Laboratories, Inc.",
                "Dolgencorp Inc",
                "Deseret Biologicals, Inc.",
                "Oncora Pharma, LLC",
                "Premier Brands of America, Inc.",
                "Rite Aid",
                "Rida LLC",
                "Wal-Mart Stores Inc.",
                "STRATEGIC SOURCING SERVICES LLC",
                "Kramer Laboratories",
                "J&A Digital Inc.",
                "Universal Distribution Center LLC",
                "Allegis Holdings LLC",
                "Trifluent Pharma LLC",
                "Kenvue Brands LLC",
                "New World Imports, Inc.",
                "Aero Healthcare US LLC",
                "Crane Safety LLC",
                "Haleon US Holdings LLC",
                "Family Dollar Stores, Inc",
                "THERAPLEX, LLC",
                "Renu Laboratories, LLC",
                "Rooftop Consumer Health, Inc.",
                "Solco Healthcare LLC",
                "GERI-GENTLE CORPORATION",
                "Walgreens Company",
                "Rugby Laboratories",
                "JHK Inc dba American Safety & First Aid",
                "Unishield",
                "Derm Ventures LLC",
                "ViaDerma Distribution, Inc.",
                "ELIXIR HEALTHCARE USA, LLC.",
                "Actavis Pharma, Inc.",
                "CVS PHARMACY, INC",
                "Walgreens Co.",
                "Topiderm, Inc.",
                "A2A Integrated Pharmaceuticals, LLC",
                "Pharmacia & Upjohn Company LLC",
                "WeCare Products LLC",
                "Mission Pharmacal Company",
                "CVS Health",
                "DISCOUNT DRUG MART, INC.",
                "Westlake Pharma LLC",
                "Mylan Pharmaceuticals Inc.",
                "Claridei Laboratories",
                "Melaleuca, Inc.",
                "Natureplex, LLC",
                "Guangdong Quadrant Ecological Technology Co., Ltd.",
                "AMERISOURCE BERGEN",
                "Reckitt Benckiser LLC",
                "Beiersdorf Inc",
                "Neilmed Pharmaceuticals Inc.",
                "Vi Medical Products Inc.",
                "Safetec of America, Inc.",
                "CP Skin Health Group, Inc.",
                "Strategic Sourcing Services LLC",
                "Vege Labs LLC.",
                "Fourstar Group USA, Inc.",
                "Leading Pharma, LLC",
                "FSA Store Inc.",
                "Chartwell RX LLC",
                "Costco Wholesale Company",
                "Meijer Distribution Inc.",
                "Medrock Pharmacy LLC",
                "Cintas Corporation",
                "Salix Pharmaceuticals, Inc",
                "Alumier Labs",
                "Pharmaceutical Specialties, Inc.",
                "Natural Essentials, Inc.",
                "Clinical Formula LLC",
                "Dynarex Corporation",
                "L'Oreal USA Products Inc.",
                "Walgreen Co.",
                "PHARMACY CHOICE INC",
                "Mericon Industries",
                "Wal-Mart Stores, Inc.",
                "Medline Industries, LP"
              ],
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                "2c27a466-defa-b729-e063-6394a90a61d3"
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                "73057-386-08"
              ],
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            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "TRADJENTA",
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            "drugstructuredosageunit": "003",
            "drugadministrationroute": "048",
            "drugindication": "Product used for unknown indication",
            "activesubstance": {
              "activesubstancename": "LINAGLIPTIN"
            },
            "openfda": {
              "application_number": [
                "NDA201280"
              ],
              "brand_name": [
                "TRADJENTA"
              ],
              "generic_name": [
                "LINAGLIPTIN"
              ],
              "manufacturer_name": [
                "Boehringer Ingelheim Pharmaceuticals, Inc."
              ],
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                "0597-0140"
              ],
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                "HUMAN PRESCRIPTION DRUG"
              ],
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              ],
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                "LINAGLIPTIN"
              ],
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                "1100702",
                "1100706"
              ],
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                "80d5d700-e711-462e-b291-3684a78d00b8"
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                "c797ea5c-cab7-494b-9044-27eba0cfe40f"
              ],
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                "0597-0140-61"
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                "N0000175913"
              ],
              "pharm_class_moa": [
                "Dipeptidyl Peptidase 4 Inhibitors [MoA]"
              ],
              "pharm_class_epc": [
                "Dipeptidyl Peptidase 4 Inhibitor [EPC]"
              ],
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                "3X29ZEJ4R2"
              ]
            }
          },
          {
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            "medicinalproduct": "VERZENIO",
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            "drugstructuredosageunit": "003",
            "drugseparatedosagenumb": "2",
            "drugintervaldosageunitnumb": "1",
            "drugintervaldosagedefinition": "804",
            "drugadministrationroute": "048",
            "drugindication": "Product used for unknown indication",
            "activesubstance": {
              "activesubstancename": "ABEMACICLIB"
            },
            "openfda": {
              "application_number": [
                "NDA208716"
              ],
              "brand_name": [
                "VERZENIO"
              ],
              "generic_name": [
                "ABEMACICLIB"
              ],
              "manufacturer_name": [
                "Eli Lilly and Company"
              ],
              "product_ndc": [
                "0002-4483",
                "0002-4815",
                "0002-5337",
                "0002-6216"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "ABEMACICLIB"
              ],
              "rxcui": [
                "1946830",
                "1946836",
                "1946838",
                "1946840",
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                "1946844",
                "1946846",
                "1946848"
              ],
              "spl_id": [
                "5b2d0f4e-5bba-4048-a2f0-bcb4b779efc0"
              ],
              "spl_set_id": [
                "be4bc0de-0fdc-4d46-8d25-be43c79e6a06"
              ],
              "package_ndc": [
                "0002-4483-54",
                "0002-4483-62",
                "0002-4815-54",
                "0002-4815-62",
                "0002-5337-54",
                "0002-5337-63",
                "0002-5337-62",
                "0002-6216-54"
              ],
              "nui": [
                "N0000175605",
                "N0000175082"
              ],
              "pharm_class_epc": [
                "Kinase Inhibitor [EPC]"
              ],
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                "Kinase Inhibitors [MoA]"
              ],
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                "60UAB198HK"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "CANNABIDIOL",
            "drugindication": "Product used for unknown indication",
            "activesubstance": {
              "activesubstancename": "CANNABIDIOL"
            },
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                "NDA210365"
              ],
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                "EPIDIOLEX"
              ],
              "generic_name": [
                "CANNABIDIOL"
              ],
              "manufacturer_name": [
                "Jazz Pharmaceuticals, Inc."
              ],
              "product_ndc": [
                "70127-100"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "ORAL"
              ],
              "substance_name": [
                "CANNABIDIOL"
              ],
              "rxcui": [
                "2058900",
                "2058906"
              ],
              "spl_id": [
                "1eb7ac65-8df5-4a4a-9156-802cfaa92b06"
              ],
              "spl_set_id": [
                "8bf27097-4870-43fb-94f0-f3d0871d1eec"
              ],
              "package_ndc": [
                "70127-100-01",
                "70127-100-10",
                "70127-100-06",
                "70127-100-60"
              ],
              "nui": [
                "M0003267",
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                "N0000191278",
                "N0000191273",
                "N0000182138",
                "N0000182139",
                "N0000187064"
              ],
              "pharm_class_cs": [
                "Cannabinoids [CS]"
              ],
              "pharm_class_moa": [
                "Cytochrome P450 2C8 Inhibitors [MoA]",
                "Cytochrome P450 2C9 Inhibitors [MoA]",
                "Cytochrome P450 2C19 Inhibitors [MoA]",
                "UGT1A9 Inhibitors [MoA]",
                "UGT2B7 Inhibitors [MoA]",
                "Cytochrome P450 1A2 Inhibitors [MoA]",
                "Cytochrome P450 2B6 Inhibitors [MoA]",
                "Cytochrome P450 2B6 Inducers [MoA]"
              ],
              "unii": [
                "19GBJ60SN5"
              ]
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "BIOTENE NOS",
            "drugindication": "Product used for unknown indication",
            "activesubstance": {
              "activesubstancename": "CETYLPYRIDINIUM CHLORIDE OR SODIUM FLUORIDE OR SODIUM MONOFLUOROPHOSPHATE OR GLUCOSE OXIDASE\\LACTOFE"
            }
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "VITAMIN B COMPLEX",
            "drugindication": "Product used for unknown indication",
            "activesubstance": {
              "activesubstancename": "CYANOCOBALAMIN\\DEXPANTHENOL\\NIACINAMIDE\\PYRIDOXINE HYDROCHLORIDE\\RIBOFLAVIN 5^-PHOSPHATE SODIUM\\THIA"
            },
            "openfda": {
              "brand_name": [
                "VITAMIN B COMPLEX"
              ],
              "generic_name": [
                "THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE"
              ],
              "manufacturer_name": [
                "Mylan Institutional LLC"
              ],
              "product_ndc": [
                "67457-146"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS"
              ],
              "substance_name": [
                "THIAMINE HYDROCHLORIDE",
                "RIBOFLAVIN 5'-PHOSPHATE SODIUM",
                "DEXPANTHENOL",
                "NIACINAMIDE",
                "PYRIDOXINE HYDROCHLORIDE"
              ],
              "rxcui": [
                "801177"
              ],
              "spl_id": [
                "a7704aa3-bd3d-479e-8469-767d59636c7e"
              ],
              "spl_set_id": [
                "282ccec8-9bcd-4571-9b91-bbb96ef2620d"
              ],
              "package_ndc": [
                "67457-146-30"
              ],
              "unii": [
                "M572600E5P",
                "20RD1DZH99",
                "1O6C93RI7Z",
                "25X51I8RD4",
                "68Y4CF58BV"
              ]
            }
          }
        ],
        "summary": {
          "narrativeincludeclinical": "CASE EVENT DATE: 20230811"
        }
      }
    }
  ]
}