{
  "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": "20240628",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "78942",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761378s000lbl.pdf",
              "date": "20240701",
              "type": "Label"
            },
            {
              "id": "78969",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761378Orig1s000ltr.pdf",
              "date": "20240702",
              "type": "Letter"
            },
            {
              "id": "81627",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761378Orig1s000TOC.html",
              "date": "20250318",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20250417",
          "review_priority": "N/A",
          "submission_class_code": "S",
          "submission_class_code_description": "Supplement",
          "application_docs": [
            {
              "id": "82033",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761378Orig1s001ltr.pdf",
              "date": "20250428",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "BLA761378",
      "sponsor_name": "FORMYCON AG",
      "openfda": {
        "application_number": [
          "BLA761378"
        ],
        "brand_name": [
          "AHZANTIVE"
        ],
        "generic_name": [
          "AFLIBERCEPT-MRBB"
        ],
        "manufacturer_name": [
          "Valorum Biologics, LLC"
        ],
        "product_ndc": [
          "85006-2908"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVITREAL"
        ],
        "substance_name": [
          "AFLIBERCEPT-MRBB"
        ],
        "rxcui": [
          "2706533",
          "2706541"
        ],
        "spl_id": [
          "42277606-719f-1fd3-e063-6394a90ad9d6"
        ],
        "spl_set_id": [
          "289e4b90-f741-c0f6-e063-6394a90a2068"
        ],
        "package_ndc": [
          "85006-2908-1"
        ],
        "unii": [
          "15C2VL427D"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "AHZANTIVE",
          "active_ingredients": [
            {
              "name": "AFLIBERCEPT-MRBB",
              "strength": "2MG(0.05ML OF 40MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}