{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20180320",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "53080",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761067Orig1s000REPLACEMENT_ltr.pdf",
              "date": "20180322",
              "type": "Letter"
            },
            {
              "id": "53248",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf",
              "date": "20180323",
              "type": "Label"
            },
            {
              "id": "53249",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf#page=10",
              "date": "20180323",
              "type": "Medication Guide"
            },
            {
              "id": "53824",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761067Orig1s000TOC.html",
              "date": "20180426",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20240403",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "78064",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761067Orig1s018ltr.pdf",
              "date": "20240404",
              "type": "Letter"
            },
            {
              "id": "78072",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761067s018lbl.pdf",
              "date": "20240404",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20251212",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "84417",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761067Orig1s024ltr.pdf",
              "date": "20251215",
              "type": "Letter"
            },
            {
              "id": "84451",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761067s024lbl.pdf",
              "date": "20251218",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20221219",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "72962",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761067s014lbl.pdf",
              "date": "20221221",
              "type": "Label"
            },
            {
              "id": "72981",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761067Orig1s014ltr.pdf",
              "date": "20221221",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "BLA761067",
      "sponsor_name": "SUN PHARMA GLOBAL",
      "openfda": {
        "application_number": [
          "BLA761067"
        ],
        "brand_name": [
          "ILUMYA"
        ],
        "generic_name": [
          "TILDRAKIZUMAB-ASMN"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-177"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "TILDRAKIZUMAB"
        ],
        "rxcui": [
          "2053453",
          "2053458"
        ],
        "spl_id": [
          "7718538c-3c74-4470-9951-cf9634ab2f31"
        ],
        "spl_set_id": [
          "c6a322bb-51b9-4f0e-8642-62a9682ffcde"
        ],
        "package_ndc": [
          "47335-177-10",
          "47335-177-01",
          "47335-177-95",
          "47335-177-96"
        ],
        "nui": [
          "N0000192799",
          "N0000192798"
        ],
        "pharm_class_epc": [
          "Interleukin-23 Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "Interleukin-23 Antagonists [MoA]"
        ],
        "unii": [
          "DEW6X41BEK"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "ILUMYA",
          "active_ingredients": [
            {
              "name": "TILDRAKIZUMAB-ASMN",
              "strength": "100MG/1ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}