{
  "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": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20241011",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "79877",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s019lbl.pdf",
              "date": "20241014",
              "type": "Label"
            },
            {
              "id": "79905",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761049Orig1s019ltr.pdf",
              "date": "20241015",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20200630",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "63762",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s009lbl.pdf",
              "date": "20200701",
              "type": "Label"
            },
            {
              "id": "63775",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761049Orig1s009ltr.pdf",
              "date": "20200701",
              "type": "Letter"
            },
            {
              "id": "65153",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761049Orig1s009.pdf",
              "date": "20201104",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20230906",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "75362",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761049Orig1s015ltr.pdf",
              "date": "20230907",
              "type": "Letter"
            },
            {
              "id": "75368",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761049s015lbl.pdf",
              "date": "20230907",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20250604",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "82467",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761049s021lbl.pdf",
              "date": "20250605",
              "type": "Label"
            },
            {
              "id": "82469",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761049Orig1s021ltr.pdf",
              "date": "20250605",
              "type": "Letter"
            },
            {
              "id": "82472",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761049s021lbl.pdf#page=36",
              "date": "20250606",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20220715",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "71583",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761049Orig1s013ltr.pdf",
              "date": "20220718",
              "type": "Letter"
            },
            {
              "id": "71597",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761049s013lbl.pdf",
              "date": "20220719",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20201110",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "65189",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761049Orig1s005ltr.pdf",
              "date": "20201112",
              "type": "Letter"
            },
            {
              "id": "65208",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s005lbl.pdf",
              "date": "20201113",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20170323",
          "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": "47651",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s000lbl.pdf",
              "date": "20170323",
              "type": "Label"
            },
            {
              "id": "47662",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s000ltredt.pdf",
              "date": "20170324",
              "type": "Letter"
            },
            {
              "id": "48227",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761049Orig1s000TOC.html",
              "date": "20170502",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20181019",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "56077",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761049Orig1s003ltr.pdf",
              "date": "20181023",
              "type": "Letter"
            },
            {
              "id": "56125",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761049s003lbl.pdf",
              "date": "20181026",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20170425",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "48150",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s001ltr.pdf",
              "date": "20170427",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20240306",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "77763",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s016lbl.pdf",
              "date": "20240308",
              "type": "Label"
            },
            {
              "id": "77784",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761049Orig1s016ltr.pdf",
              "date": "20240312",
              "type": "Letter"
            },
            {
              "id": "77786",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761049Origs016ltr.pdf",
              "date": "20240312",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20241126",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "80437",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761049Orig1s020ltr.pdf",
              "date": "20241129",
              "type": "Letter"
            },
            {
              "id": "80461",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s020lbl.pdf",
              "date": "20241202",
              "type": "Label"
            },
            {
              "id": "80462",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s020lbl.pdf#page=36",
              "date": "20241202",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20190514",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "58712",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761049s006lbl.pdf",
              "date": "20190515",
              "type": "Label"
            },
            {
              "id": "58730",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761049Orig1s006ltr.pdf",
              "date": "20190515",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20171012",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "50178",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s002lbl.pdf",
              "date": "20171025",
              "type": "Label"
            },
            {
              "id": "50215",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s002ltr.pdf",
              "date": "20171030",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "BLA761049",
      "sponsor_name": "EMD SERONO INC",
      "openfda": {
        "application_number": [
          "BLA761049"
        ],
        "brand_name": [
          "BAVENCIO"
        ],
        "generic_name": [
          "AVELUMAB"
        ],
        "manufacturer_name": [
          "EMD Serono, Inc."
        ],
        "product_ndc": [
          "44087-3535"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "AVELUMAB"
        ],
        "rxcui": [
          "1875542",
          "1875547"
        ],
        "spl_id": [
          "8e1f3b1c-5aab-408c-930e-619daa6afa8a"
        ],
        "spl_set_id": [
          "5cd725a1-2fa4-408a-a651-57a7b84b2118"
        ],
        "package_ndc": [
          "44087-3535-1"
        ],
        "nui": [
          "N0000193338",
          "N0000193337",
          "N0000193336",
          "M0001357"
        ],
        "pharm_class_epc": [
          "Programmed Death Ligand-1 Blocker [EPC]"
        ],
        "pharm_class_moa": [
          "Programmed Death Ligand-1 Antagonists [MoA]",
          "Programmed Death Ligand-1-directed Antibody Interactions [MoA]"
        ],
        "pharm_class_cs": [
          "Antibodies, Monoclonal [CS]"
        ],
        "unii": [
          "KXG2PJ551I"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "BAVENCIO",
          "active_ingredients": [
            {
              "name": "AVELUMAB",
              "strength": "20MG/ML"
            }
          ],
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}