{
  "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": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20190516",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "58777",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761091Orig1s001, s002ltr.pdf",
              "date": "20190517",
              "type": "Letter"
            },
            {
              "id": "58779",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761091s001s002lbl.pdf",
              "date": "20190517",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20190516",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "58776",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761091Orig1s001, s002ltr.pdf",
              "date": "20190517",
              "type": "Letter"
            },
            {
              "id": "58780",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761091s001s002lbl.pdf",
              "date": "20190517",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20181214",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "56747",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761091s000lbl.pdf",
              "date": "20181214",
              "type": "Label"
            },
            {
              "id": "56911",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761091Orig1s000ltr.pdf",
              "date": "20181221",
              "type": "Letter"
            },
            {
              "id": "58058",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761091Orig1s000TOC.html",
              "date": "20190321",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20250522",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "82333",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761091Orig1s035ltr.pdf",
              "date": "20250527",
              "type": "Letter"
            },
            {
              "id": "82412",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761091s035lbl.pdf",
              "date": "20250602",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20241113",
          "review_priority": "STANDARD",
          "submission_class_code": "BIOSIMILAR",
          "application_docs": [
            {
              "id": "80211",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761091s033lbl.pdf",
              "date": "20241114",
              "type": "Label"
            },
            {
              "id": "80218",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761091Orig1s033ltr.pdf",
              "date": "20241114",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "BLA761091",
      "sponsor_name": "CELLTRION INC",
      "openfda": {
        "application_number": [
          "BLA761091"
        ],
        "brand_name": [
          "HERZUMA"
        ],
        "generic_name": [
          "TRASTUZUMAB"
        ],
        "manufacturer_name": [
          "Cephalon, Inc."
        ],
        "product_ndc": [
          "63459-303",
          "63459-305"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "TRASTUZUMAB"
        ],
        "rxcui": [
          "2107053",
          "2107058",
          "2169359",
          "2169362"
        ],
        "spl_id": [
          "49f6182a-5e0f-45ea-8a0f-b774ef28a98f"
        ],
        "spl_set_id": [
          "ae71c003-883a-4cd8-ad50-e8cc9a54e971"
        ],
        "package_ndc": [
          "63459-305-47",
          "63459-307-41",
          "63459-221-20",
          "63459-303-43"
        ],
        "nui": [
          "N0000175661",
          "N0000020008"
        ],
        "pharm_class_epc": [
          "HER2/neu Receptor Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "HER2/Neu/cerbB2 Antagonists [MoA]"
        ],
        "unii": [
          "P188ANX8CK"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "HERZUMA",
          "active_ingredients": [
            {
              "name": "TRASTUZUMAB-PKRB",
              "strength": "420MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}