{
  "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": "2026-06-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "5003",
          "submission_status": "AP",
          "submission_status_date": "20010323",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39684",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/basnova032301LB.pdf",
              "date": "20040329",
              "type": "Label"
            },
            {
              "id": "9428",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/basnova032301L.htm",
              "date": "20040329",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5046",
          "submission_status": "AP",
          "submission_status_date": "20030527",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5040",
          "submission_status": "AP",
          "submission_status_date": "20031114",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "31630",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103764-5040ltr.pdf",
              "date": "20031204",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1010",
          "submission_status": "AP",
          "submission_status_date": "20010322",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5006",
          "submission_status": "AP",
          "submission_status_date": "20011129",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5059",
          "submission_status": "AP",
          "submission_status_date": "20050915",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19980512",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "43278",
              "url": "https://web.archive.org/web/20170113111552/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093359.htm",
              "date": "20040329",
              "type": "Review"
            },
            {
              "id": "18623",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/basnov051298lb.pdf",
              "date": "20040329",
              "type": "Label"
            },
            {
              "id": "31629",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/basnov051298L.htm",
              "date": "20040329",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5037",
          "submission_status": "AP",
          "submission_status_date": "20030102",
          "submission_class_code": "S",
          "submission_class_code_description": "Supplement",
          "application_docs": [
            {
              "id": "39685",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/basnov010203LB.htm",
              "date": "20040329",
              "type": "Label"
            },
            {
              "id": "9429",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/basnov010203L.htm",
              "date": "20040329",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "BLA103764",
      "sponsor_name": "NOVARTIS",
      "openfda": {
        "application_number": [
          "BLA103764"
        ],
        "brand_name": [
          "SIMULECT"
        ],
        "generic_name": [
          "BASILIXIMAB"
        ],
        "manufacturer_name": [
          "Novartis Pharmaceuticals Corporation"
        ],
        "product_ndc": [
          "0078-0331",
          "0078-0393"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "BASILIXIMAB"
        ],
        "rxcui": [
          "1656643",
          "1656646",
          "1656648",
          "1656650"
        ],
        "spl_id": [
          "3a12b631-15b1-4b4a-a018-692037cc4709"
        ],
        "spl_set_id": [
          "1af01887-b69d-444b-91ed-ebfe12784440"
        ],
        "package_ndc": [
          "0078-0393-61",
          "0078-0331-84"
        ],
        "nui": [
          "N0000010279",
          "N0000175621",
          "N0000175622"
        ],
        "pharm_class_moa": [
          "Interleukin 2 Receptor Antagonists [MoA]",
          "Interleukin 2 Receptor-directed Antibody Interactions [MoA]"
        ],
        "pharm_class_epc": [
          "Interleukin-2 Receptor Blocking Antibody [EPC]"
        ],
        "unii": [
          "9927MT646M"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "SIMULECT",
          "active_ingredients": [
            {
              "name": "BASILIXIMAB",
              "strength": "20MG"
            }
          ],
          "dosage_form": "VIAL",
          "route": "SINGLE-USE",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "SIMULECT",
          "active_ingredients": [
            {
              "name": "BASILIXIMAB",
              "strength": "10MG"
            }
          ],
          "dosage_form": "VIAL",
          "route": "SINGLE-USE",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}