{
  "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": "2026-04-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 86434
    }
  },
  "results": [
    {
      "safetyreportversion": "1",
      "safetyreportid": "10004203",
      "primarysourcecountry": "AU",
      "occurcountry": "AU",
      "transmissiondateformat": "102",
      "transmissiondate": "20141002",
      "reporttype": "2",
      "serious": "1",
      "seriousnessother": "1",
      "receivedateformat": "102",
      "receivedate": "20140312",
      "receiptdateformat": "102",
      "receiptdate": "20140312",
      "fulfillexpeditecriteria": "1",
      "companynumb": "AU-TEVA-467680USA",
      "duplicate": "1",
      "reportduplicate": {
        "duplicatesource": "TEVA",
        "duplicatenumb": "AU-TEVA-467680USA"
      },
      "primarysource": {
        "reportercountry": "AU",
        "qualification": "1"
      },
      "sender": {
        "sendertype": "2",
        "senderorganization": "FDA-Public Use"
      },
      "receiver": {
        "receivertype": "6",
        "receiverorganization": "FDA"
      },
      "patient": {
        "patientonsetage": "60",
        "patientonsetageunit": "801",
        "patientsex": "1",
        "reaction": [
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Malignant neoplasm progression",
            "reactionoutcome": "6"
          },
          {
            "reactionmeddraversionpt": "17.0",
            "reactionmeddrapt": "Pancytopenia",
            "reactionoutcome": "6"
          }
        ],
        "drug": [
          {
            "drugcharacterization": "1",
            "medicinalproduct": "BENDAMUSTINE",
            "drugauthorizationnumb": "022249",
            "drugadministrationroute": "065",
            "drugindication": "B-CELL LYMPHOMA STAGE IV",
            "actiondrug": "5",
            "openfda": {
              "application_number": [
                "ANDA211001"
              ],
              "brand_name": [
                "BENDAMUSTINE"
              ],
              "generic_name": [
                "BENDAMUSTINE HCL"
              ],
              "manufacturer_name": [
                "Meitheal Pharmaceuticals Inc."
              ],
              "product_ndc": [
                "71288-102",
                "71288-103"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS"
              ],
              "substance_name": [
                "BENDAMUSTINE HYDROCHLORIDE"
              ],
              "spl_id": [
                "c4d02b46-b7dc-4c54-9f17-49f378437808"
              ],
              "spl_set_id": [
                "40f6f58d-d9ac-4f65-9fc7-16984bf1f180"
              ],
              "package_ndc": [
                "71288-102-10",
                "71288-103-20"
              ],
              "unii": [
                "981Y8SX18M"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "RITUXIMAB",
            "drugdosagetext": "UNKNOWN/D",
            "drugadministrationroute": "065",
            "drugindication": "B-CELL LYMPHOMA STAGE IV",
            "actiondrug": "5",
            "openfda": {
              "application_number": [
                "BLA103705"
              ],
              "brand_name": [
                "RITUXAN"
              ],
              "generic_name": [
                "RITUXIMAB"
              ],
              "manufacturer_name": [
                "Genentech, Inc."
              ],
              "product_ndc": [
                "50242-051",
                "50242-053"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS"
              ],
              "substance_name": [
                "RITUXIMAB"
              ],
              "rxcui": [
                "1657862",
                "1657864",
                "1657867",
                "1657868"
              ],
              "spl_id": [
                "3a716937-c2af-4bf9-976c-c34746b22ff0"
              ],
              "spl_set_id": [
                "b172773b-3905-4a1c-ad95-bab4b6126563"
              ],
              "package_ndc": [
                "50242-051-21",
                "50242-051-10",
                "50242-053-06"
              ],
              "nui": [
                "N0000175078",
                "N0000175657"
              ],
              "pharm_class_moa": [
                "CD20-directed Antibody Interactions [MoA]"
              ],
              "pharm_class_epc": [
                "CD20-directed Cytolytic Antibody [EPC]"
              ],
              "unii": [
                "4F4X42SYQ6"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "PREDNISONE /00044702/",
            "drugadministrationroute": "065",
            "drugindication": "B-CELL LYMPHOMA STAGE IV",
            "actiondrug": "5"
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "CYCLOPHOSPHAMIDE",
            "drugindication": "B-CELL LYMPHOMA STAGE IV",
            "actiondrug": "5",
            "openfda": {
              "application_number": [
                "ANDA218632",
                "ANDA211757",
                "ANDA211608",
                "ANDA040745",
                "NDA210852",
                "ANDA215892",
                "ANDA218282",
                "NDA212501",
                "ANDA210046",
                "ANDA204555",
                "ANDA218644",
                "NDA012141",
                "NDA203856",
                "ANDA216783",
                "ANDA214529",
                "NDA210735",
                "NDA217150",
                "NDA217651"
              ],
              "brand_name": [
                "CYCLOPHOSPHAMIDE",
                "FRINDOVYX"
              ],
              "generic_name": [
                "CYCLOPHOSPHAMIDE FOR INJECTION",
                "CYCLOPHOSPHAMIDE",
                "CYCLOPHOSPHAMIDE INJECTION, SOLUTION"
              ],
              "manufacturer_name": [
                "Slate Run Pharmaceuticals, LLC",
                "XGen Pharmaceuticals DJB, Inc.",
                "Cipla USA Inc.",
                "Civica, Inc.",
                "Avyxa Pharma, LLC",
                "Alembic Pharmaceuticals Inc.",
                "OPKO Pharmaceuticals, LLC",
                "Dr. Reddy's Labratories Inc.",
                "Baxter Healthcare Corporation",
                "Amneal Pharmaceuticals LLC",
                "Fresenius Kabi USA, LLC",
                "Sandoz Inc.",
                "BluePoint Laboratories",
                "Hikma Pharmaceuticals USA Inc.",
                "Nexus Pharmaceuticals, LLC",
                "Sagent Pharmaceuticals",
                "Alembic Pharmaceuticals Limited",
                "Epic Pharma, LLC",
                "Eugia US LLC",
                "Hainan Poly Pharm. Co., Ltd.",
                "Sandoz Inc",
                "NorthStar RxLLC",
                "Avenacy, LLC",
                "Bamboo US Bidco LCC",
                "Baxter Healthcare Company",
                "NorthStar Rx LLC"
              ],
              "product_ndc": [
                "70436-105",
                "70436-106",
                "70436-107",
                "39822-0250",
                "39822-0255",
                "39822-0260",
                "69097-516",
                "69097-517",
                "72572-083",
                "72572-085",
                "72572-087",
                "83831-119",
                "83831-120",
                "83831-121",
                "62332-618",
                "62332-619",
                "70301-2013",
                "75907-189",
                "75907-191",
                "75907-190",
                "10019-943",
                "10019-944",
                "10019-945",
                "70121-1238",
                "70121-1239",
                "70121-1240",
                "10019-935",
                "10019-936",
                "10019-937",
                "65219-131",
                "65219-135",
                "65219-133",
                "0781-3233",
                "0781-3244",
                "0781-3255",
                "10019-955",
                "10019-956",
                "10019-957",
                "68001-694",
                "68001-695",
                "68001-696",
                "10019-938",
                "10019-939",
                "10019-942",
                "68001-564",
                "68001-563",
                "68001-565",
                "10019-982",
                "10019-984",
                "0054-0382",
                "0054-0383",
                "14789-125",
                "14789-126",
                "25021-247",
                "25021-248",
                "25021-249",
                "70301-2015",
                "46708-618",
                "46708-619",
                "42806-901",
                "42806-902",
                "42806-903",
                "55150-270",
                "55150-271",
                "55150-272",
                "14335-470",
                "14335-471",
                "14335-472",
                "0781-3528",
                "0781-3529",
                "0781-3530",
                "72603-326",
                "72603-104",
                "72603-411",
                "83831-116",
                "83831-117",
                "83831-118",
                "68001-442",
                "68001-443",
                "68001-444",
                "83634-205",
                "83634-206",
                "83634-207",
                "83703-549",
                "83703-550",
                "83703-551",
                "0338-9777",
                "0338-9779",
                "16714-857",
                "16714-859",
                "16714-858"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS",
                "ORAL"
              ],
              "substance_name": [
                "CYCLOPHOSPHAMIDE",
                "CYCLOPHOSPHAMIDE ANHYDROUS"
              ],
              "rxcui": [
                "1734917",
                "1734919",
                "1734921",
                "1437968",
                "1437969",
                "2703027",
                "2703032",
                "2386859",
                "197549",
                "197550",
                "2568661",
                "2568663",
                "2679073",
                "2644738",
                "2644751",
                "2644824"
              ],
              "spl_id": [
                "31c60f0f-f81b-a187-e063-6394a90aa39d",
                "29b88d00-eeea-7282-e063-6294a90a4024",
                "11c7b59d-18e5-4efb-bc77-5877d9b89bb1",
                "474c3902-b6cc-4ee3-81e3-317e9bbcabcd",
                "8a1dd776-1219-455e-a47f-bc6fc921c15c",
                "c4d00f29-b259-4ba5-933b-3908870376d8",
                "5100a9aa-5e4b-1edb-e063-6294a90a174e",
                "81f6f0e0-48f4-4eb1-95e5-b1463e5f53f5",
                "b9af2b33-4e49-458b-8962-183830fdd895",
                "40ce8341-9b51-4187-920b-ad9cce7930e1",
                "b745f3eb-670e-494a-bc38-210549c8681e",
                "fadfc813-11a5-415a-9d70-06c579e7619c",
                "2f9d08d0-1f6c-0bf3-e063-6394a90a2b6f",
                "2e97b53e-e39d-4190-9091-b8856a7cff7b",
                "4cd3801f-1a1a-33fd-e063-6294a90aa2b0",
                "1805411d-b1c7-47ef-8c74-bb81a5acd964",
                "3bc6345d-4340-1f0f-e063-6294a90ac0a9",
                "64432fde-275f-41de-a67c-2feb02b69321",
                "35c0ebb6-6127-4e3a-9846-4ad17f7d5cd4",
                "4e548b5c-d8d1-0f7a-e063-6294a90ae76e",
                "5ed11ef9-73c0-42d1-9cac-0fba10a1f991",
                "4ffc80f0-4804-ada3-e063-6294a90acf7b",
                "9c04aa3c-6a2b-4ad4-b3df-87cc168cf93d",
                "14b3b66b-0e87-4e71-8507-e23c8214cc50",
                "f90b3bb0-87cd-4951-9789-34202e2b13df",
                "2aca7731-9fcc-4625-e063-6394a90a6020",
                "3a7a4ad7-90ca-4d84-92f1-c61032067deb",
                "2eac820a-3535-4167-9a24-11f42ec961ef",
                "5fc45658-c2d9-41de-821f-ff6f40a469dd",
                "4a9e24ce-e6fc-6f07-e063-6394a90ab4bd",
                "fd5fc06c-b5e5-4e07-acdb-26e56bfa2c7f",
                "450da59c-b50e-4de0-e063-6394a90a0559",
                "4f8ec65c-284b-4a7e-86d6-d3ced9cef625",
                "27e82150-4ad3-5be6-e063-6394a90a0e3f"
              ],
              "spl_set_id": [
                "20bda486-cb9a-4d67-8c41-50e9fd066434",
                "02e64046-687d-449e-e063-6294a90a6c32",
                "0e1cb955-99c8-4fe5-89d1-399c8e52174e",
                "8627c83f-c057-495d-9f78-8b67bda97b3e",
                "5ad8ea65-4c98-487a-9c8d-df778765ec5e",
                "3d6e68b1-5120-4cbb-a9d2-fb09d1b74ea1",
                "d8057d1a-e8af-42ab-9da2-b545730b2655",
                "a5818647-d840-e9d7-c7b8-6541b485e44e",
                "cef038cc-efab-46d9-99c2-95bb11d6c9bc",
                "520bfe39-dfd5-4a20-9a37-80078afded0d",
                "6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe",
                "31986d36-a1bf-4903-93a4-ce7386241ba1",
                "0e9e22fa-178a-42fc-9f82-c303db3b245a",
                "591d9955-3d9c-4cdc-a308-2f1288376b9f",
                "1d3396d8-4c03-4a28-890a-d87c6c53a74e",
                "97ab446f-5017-4180-ae65-0a355289b0ed",
                "0afd2cc7-09e6-481a-afea-9d2e3742da46",
                "769ded74-6186-40a8-8e44-ceff67287451",
                "8135b917-882f-4b4c-99b7-fa8ea54af4bf",
                "c961a1ac-6705-4756-9abc-9d84a6fcb5c8",
                "329b5a3a-c7b9-4b11-abf0-009719cdfb79",
                "7d6447e3-22c9-48d9-87c0-d0b576d7ea9e",
                "9e699cf7-860e-4c03-9760-0c24d56df2de",
                "988d2f71-1dc7-45b5-b2df-187e68224973",
                "3c1eb470-0bba-457d-94e3-b9508f0d398a",
                "6fde2705-a2d8-4d48-9618-b9d99d051373",
                "cf2f4b95-0327-499a-a5a3-51b1bdef68c5",
                "fdaa7d15-7c06-44ab-b1d5-9d2b3e8ffd28",
                "6f593585-e0dd-48bc-bd2b-c6c787e0b98c",
                "d7e97b99-83db-42d0-8521-b87fe6467a67",
                "1de02105-9c5b-4d11-bddf-bf8450d88b78",
                "2873b99a-830d-0a7b-e063-6394a90a4de7",
                "34dbffee-80e0-49c3-90e8-95713a0b7fbe",
                "76f057be-e3da-0a89-e053-2a91aa0a8438"
              ],
              "package_ndc": [
                "70436-105-80",
                "70436-106-80",
                "70436-107-80",
                "39822-0255-1",
                "39822-0250-1",
                "39822-0260-1",
                "69097-516-07",
                "69097-517-07",
                "72572-085-01",
                "72572-083-01",
                "72572-087-01",
                "83831-119-01",
                "83831-120-02",
                "83831-121-04",
                "62332-618-31",
                "62332-619-31",
                "70301-2013-1",
                "75907-191-02",
                "75907-190-07",
                "75907-189-35",
                "10019-943-25",
                "10019-943-01",
                "10019-944-50",
                "10019-944-01",
                "10019-945-10",
                "10019-945-01",
                "70121-1238-1",
                "70121-1239-1",
                "70121-1240-1",
                "10019-935-25",
                "10019-935-01",
                "10019-936-50",
                "10019-936-01",
                "10019-937-10",
                "10019-937-01",
                "65219-135-20",
                "65219-131-20",
                "65219-133-20",
                "0781-3233-94",
                "0781-3244-94",
                "0781-3255-94",
                "10019-955-50",
                "10019-955-01",
                "10019-956-16",
                "10019-956-01",
                "10019-957-11",
                "10019-957-01",
                "68001-694-27",
                "68001-695-32",
                "68001-696-32",
                "10019-938-25",
                "10019-938-01",
                "10019-939-50",
                "10019-939-01",
                "10019-942-10",
                "10019-942-01",
                "68001-563-84",
                "68001-564-22",
                "68001-565-28",
                "10019-982-09",
                "10019-982-01",
                "10019-984-09",
                "10019-984-01",
                "0054-0382-13",
                "0054-0382-25",
                "0054-0383-13",
                "0054-0383-25",
                "14789-125-07",
                "14789-125-05",
                "14789-126-07",
                "14789-126-05",
                "25021-247-50",
                "25021-248-51",
                "25021-249-51",
                "70301-2015-1",
                "46708-618-31",
                "46708-619-31",
                "42806-901-26",
                "42806-902-26",
                "42806-903-26",
                "55150-270-01",
                "55150-270-99",
                "55150-271-01",
                "55150-271-99",
                "55150-272-01",
                "14335-470-01",
                "14335-470-10",
                "14335-471-01",
                "14335-471-10",
                "14335-472-01",
                "14335-472-10",
                "0781-3528-75",
                "0781-3528-10",
                "0781-3529-70",
                "0781-3529-10",
                "0781-3530-80",
                "0781-3530-10",
                "72603-104-01",
                "72603-326-01",
                "72603-411-01",
                "83831-116-01",
                "83831-117-02",
                "83831-118-04",
                "68001-442-26",
                "68001-443-27",
                "68001-444-32",
                "83634-205-50",
                "83634-206-51",
                "83634-207-51",
                "83703-549-25",
                "83703-549-01",
                "83703-550-50",
                "83703-550-01",
                "83703-551-10",
                "83703-551-01",
                "0338-9777-01",
                "0338-9779-01",
                "16714-859-01",
                "16714-857-01",
                "16714-858-01"
              ],
              "unii": [
                "8N3DW7272P",
                "6UXW23996M"
              ],
              "nui": [
                "N0000000236",
                "N0000175558"
              ],
              "pharm_class_moa": [
                "Alkylating Activity [MoA]"
              ],
              "pharm_class_epc": [
                "Alkylating Drug [EPC]"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "DOXORUBICIN",
            "actiondrug": "5",
            "openfda": {
              "application_number": [
                "ANDA208888"
              ],
              "brand_name": [
                "DOXORUBICIN HYDROCHLORIDE"
              ],
              "generic_name": [
                "DOXORUBICIN"
              ],
              "manufacturer_name": [
                "Amneal Pharmaceuticals LLC"
              ],
              "product_ndc": [
                "70121-1218",
                "70121-1219"
              ],
              "product_type": [
                "HUMAN PRESCRIPTION DRUG"
              ],
              "route": [
                "INTRAVENOUS"
              ],
              "substance_name": [
                "DOXORUBICIN HYDROCHLORIDE"
              ],
              "rxcui": [
                "1790095",
                "1872062"
              ],
              "spl_id": [
                "f4a01f55-65d7-401f-ac2f-e1511bf3a429"
              ],
              "spl_set_id": [
                "d928625e-c1ef-4f25-8d25-764c8c6aab67"
              ],
              "package_ndc": [
                "70121-1218-1",
                "70121-1218-7",
                "70121-1219-1"
              ],
              "unii": [
                "82F2G7BL4E"
              ]
            }
          },
          {
            "drugcharacterization": "1",
            "medicinalproduct": "VINCRISTINE",
            "actiondrug": "5"
          },
          {
            "drugcharacterization": "2",
            "medicinalproduct": "IBRUTINUB"
          }
        ]
      }
    }
  ]
}