{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20250325",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "81725",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761398Orig1s000lbl.pdf",
              "date": "20250325",
              "type": "Label"
            },
            {
              "id": "81745",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761398Orig1s000ltr.pdf",
              "date": "20250327",
              "type": "Letter"
            },
            {
              "id": "84320",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761398Orig1s000TOC.html",
              "date": "20251126",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20251029",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "84001",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761398Orig2s000ltr.pdf",
              "date": "20251031",
              "type": "Letter"
            },
            {
              "id": "84319",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761398Orig2s000TOC.html",
              "date": "20251126",
              "type": "Review"
            },
            {
              "id": "84322",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761398Orig2s000lbl.pdf",
              "date": "20251126",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "BLA761398",
      "sponsor_name": "FRESENIUS KABI USA LLC",
      "openfda": {
        "application_number": [
          "BLA761398"
        ],
        "brand_name": [
          "CONEXXENCE",
          "BOMYNTRA"
        ],
        "generic_name": [
          "DENOSUMAB"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "65219-668",
          "65219-670",
          "65219-672"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "DENOSUMAB"
        ],
        "rxcui": [
          "2717531",
          "2717538",
          "2717542",
          "2717549",
          "2717551",
          "2717555"
        ],
        "spl_id": [
          "f778a079-d075-4205-bc94-8ec67e27c95e",
          "fd3a3b73-bf8e-4538-9eee-b3d652251260"
        ],
        "spl_set_id": [
          "39a0a789-778f-4695-b3a9-61643e6396cd",
          "49d25732-e05d-47e4-98cb-67df04796d4b"
        ],
        "package_ndc": [
          "65219-668-01",
          "65219-672-01",
          "65219-670-01"
        ],
        "nui": [
          "N0000187055",
          "N0000187054"
        ],
        "pharm_class_epc": [
          "RANK Ligand Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "RANK Ligand Blocking Activity [MoA]"
        ],
        "unii": [
          "4EQZ6YO2HI"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "CONEXXENCE",
          "active_ingredients": [
            {
              "name": "DENOSUMAB-BNHT",
              "strength": "60MG/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTION",
          "route": null,
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "BOMYNTRA",
          "active_ingredients": [
            {
              "name": "DENOSUMAB-BNHT",
              "strength": "120MG/1.7ML (70 MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTION",
          "route": null,
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}