{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20260605",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "86198",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761369Orig1s003ltr.pdf",
              "date": "20260609",
              "type": "Letter"
            },
            {
              "id": "86219",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761369s003lbl.pdf",
              "date": "20260611",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20250916",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "83363",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761369s001lbl.pdf",
              "date": "20250917",
              "type": "Label"
            },
            {
              "id": "83378",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761369Orig1s001ltr.pdf",
              "date": "20250918",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20251216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "84434",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761369Orig1s002ltr.pdf",
              "date": "20251217",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20241011",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "79908",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761369Orig1s000ltr.pdf",
              "date": "20241015",
              "type": "Letter"
            },
            {
              "id": "79912",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761369s000lbl.pdf",
              "date": "20241018",
              "type": "Label"
            },
            {
              "id": "80192",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761369Orig1s000TOC.html",
              "date": "20241112",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "BLA761369",
      "sponsor_name": "PFIZER INC",
      "openfda": {
        "application_number": [
          "BLA761369"
        ],
        "brand_name": [
          "HYMPAVZI"
        ],
        "generic_name": [
          "MARSTACIMAB-HNCQ"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc"
        ],
        "product_ndc": [
          "0069-0775",
          "0069-2151",
          "0069-1510",
          "0069-1575"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "MARSTACIMAB"
        ],
        "rxcui": [
          "2697139",
          "2697146",
          "2697150",
          "2697154",
          "2745185",
          "2745186",
          "2745187",
          "2745188"
        ],
        "spl_id": [
          "23101437-0c06-4577-aca1-32535c6f7056"
        ],
        "spl_set_id": [
          "a2cc631e-13a6-40c2-acf9-065ccedfb90a"
        ],
        "package_ndc": [
          "0069-2151-01",
          "0069-1510-01",
          "0069-0775-01",
          "0069-1575-01"
        ],
        "unii": [
          "0UB3OA67O7"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "HYMPAVZI",
          "active_ingredients": [
            {
              "name": "MARSTACIMAB-HNCQ",
              "strength": "300MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}