{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20250407",
          "review_priority": "STANDARD",
          "submission_class_code": "BIOSIMILAR",
          "application_docs": [
            {
              "id": "81840",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761219s017lbl.pdf",
              "date": "20250408",
              "type": "Label"
            },
            {
              "id": "81907",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761219Orig1s017ltr.pdf",
              "date": "20250409",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20231222",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77139",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s006; s007; s008ltr.pdf",
              "date": "20231227",
              "type": "Letter"
            },
            {
              "id": "77152",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf",
              "date": "20231227",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20230523",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 2",
          "submission_class_code_description": "Type 2 - New Active Ingredient",
          "application_docs": [
            {
              "id": "74359",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s000lbl.pdf",
              "date": "20230524",
              "type": "Label"
            },
            {
              "id": "74362",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s001ltr.pdf",
              "date": "20231003",
              "type": "Letter"
            },
            {
              "id": "75042",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761219Orig1s000TOC.html",
              "date": "20230811",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20231222",
          "review_priority": "N/A",
          "submission_class_code": "BIOEQUIV",
          "submission_class_code_description": "Bioequivalence",
          "application_docs": [
            {
              "id": "77137",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s006; s007; s008ltr.pdf",
              "date": "20231227",
              "type": "Letter"
            },
            {
              "id": "77148",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf",
              "date": "20231227",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20241223",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "80756",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761219s013lbl.pdf",
              "date": "20241227",
              "type": "Label"
            },
            {
              "id": "80761",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761219Orig1s013ltr.pdf",
              "date": "20241227",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20230921",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "75549",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s004ltr.pdf",
              "date": "20230925",
              "type": "Letter"
            },
            {
              "id": "75568",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s004lbl.pdf",
              "date": "20230926",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20240816",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "79435",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761219Orig1s011ltr.pdf",
              "date": "20240819",
              "type": "Letter"
            },
            {
              "id": "79441",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761219s011lbl.pdf",
              "date": "20240820",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20231130",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "76707",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s002lbl.pdf",
              "date": "20231201",
              "type": "Label"
            },
            {
              "id": "76715",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s002ltr.pdf",
              "date": "20231201",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20251016",
          "submission_class_code": "BIOSIMILAR",
          "application_docs": [
            {
              "id": "83806",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761219Orig1s018ltr.pdf",
              "date": "20251020",
              "type": "Letter"
            },
            {
              "id": "83873",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761219s018lbl.pdf",
              "date": "20251022",
              "type": "Label"
            },
            {
              "id": "83874",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761219s018lbl.pdf#page=49",
              "date": "20251022",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20250521",
          "review_priority": "N/A",
          "submission_class_code": "S",
          "submission_class_code_description": "Supplement",
          "application_docs": [
            {
              "id": "82216",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761219Orig1s009ltr.pdf",
              "date": "20250521",
              "type": "Letter"
            },
            {
              "id": "82227",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761219s009lbl.pdf",
              "date": "20250521",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20250521",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "82305",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761219Orig1s016ltr.pdf",
              "date": "20250523",
              "type": "Letter"
            },
            {
              "id": "82454",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761219s016lbl.pdf",
              "date": "20250603",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20231222",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77138",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s006; s007; s008ltr.pdf",
              "date": "20231227",
              "type": "Letter"
            },
            {
              "id": "77149",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf",
              "date": "20231227",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20230906",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "75363",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s003ltr.pdf",
              "date": "20230907",
              "type": "Letter"
            },
            {
              "id": "75371",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s003lbl.pdf",
              "date": "20230907",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20231002",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "75640",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s001lbl.pdf",
              "date": "20231002",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "BLA761219",
      "sponsor_name": "CELLTRION",
      "openfda": {
        "application_number": [
          "BLA761219"
        ],
        "brand_name": [
          "ADALIMUMAB",
          "YUFLYMA"
        ],
        "generic_name": [
          "ADALIMUMAB-AATY"
        ],
        "manufacturer_name": [
          "CELLTRION USA, Inc."
        ],
        "product_ndc": [
          "72606-022",
          "72606-040",
          "72606-041",
          "72606-023",
          "72606-030",
          "72606-024",
          "72606-046",
          "72606-039",
          "72606-063"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "spl_id": [
          "4ba7057b-2495-42ba-9c35-95d87449259c",
          "eb3d3caa-1cf5-402f-9d18-c1ce1c122634"
        ],
        "spl_set_id": [
          "c44365e9-d470-4e35-978d-8565a9e3471e",
          "526d626f-8c9f-496c-b838-00a73bb36383"
        ],
        "package_ndc": [
          "72606-022-01",
          "72606-022-02",
          "72606-022-03",
          "72606-022-04",
          "72606-022-05",
          "72606-022-06",
          "72606-022-07",
          "72606-022-08",
          "72606-022-09",
          "72606-022-10",
          "72606-022-11",
          "72606-022-12",
          "72606-040-01",
          "72606-040-02",
          "72606-040-03",
          "72606-040-04",
          "72606-040-05",
          "72606-040-06",
          "72606-041-01",
          "72606-030-01",
          "72606-030-02",
          "72606-030-03",
          "72606-030-04",
          "72606-030-05",
          "72606-030-06",
          "72606-030-07",
          "72606-030-08",
          "72606-030-09",
          "72606-030-10",
          "72606-030-11",
          "72606-030-12",
          "72606-030-13",
          "72606-030-14",
          "72606-023-01",
          "72606-023-02",
          "72606-023-03",
          "72606-023-04",
          "72606-023-05",
          "72606-023-07",
          "72606-023-08",
          "72606-024-01",
          "72606-046-01",
          "72606-039-01",
          "72606-063-01"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "YUFLYMA",
          "active_ingredients": [
            {
              "name": "ADALIMUMAB-AATY",
              "strength": "40MG/0.4ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}