{
  "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": "2",
          "submission_status": "AP",
          "submission_status_date": "20210211",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "66215",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211970Orig1s002ltr.pdf",
              "date": "20210216",
              "type": "Letter"
            },
            {
              "id": "66232",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211970s002lbl.pdf",
              "date": "20210216",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20240604",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "78634",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211970Orig1s010,s011ltr.pdf",
              "date": "20240702",
              "type": "Letter"
            },
            {
              "id": "78644",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211970s010s011lbl.pdf",
              "date": "20240605",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20191212",
          "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": "61260",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211970Orig1s000ltr.pdf",
              "date": "20191213",
              "type": "Letter"
            },
            {
              "id": "61266",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211970s000lbl.pdf",
              "date": "20191213",
              "type": "Label"
            },
            {
              "id": "61605",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211970Orig1s000TOC.html",
              "date": "20200121",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20240604",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "78633",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211970Orig1s010,s011ltr.pdf",
              "date": "20240702",
              "type": "Letter"
            },
            {
              "id": "78643",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211970s010s011lbl.pdf",
              "date": "20240605",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA211970",
      "sponsor_name": "SAREPTA THERAPS INC",
      "openfda": {
        "application_number": [
          "NDA211970"
        ],
        "brand_name": [
          "VYONDYS 53"
        ],
        "generic_name": [
          "GOLODIRSEN"
        ],
        "manufacturer_name": [
          "Sarepta Therapeutics, Inc."
        ],
        "product_ndc": [
          "60923-465"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GOLODIRSEN"
        ],
        "rxcui": [
          "2267211",
          "2267216"
        ],
        "spl_id": [
          "5fbaac76-f7cb-4f43-99f8-af43c2655ff0"
        ],
        "spl_set_id": [
          "35c227d1-5b24-44b0-b5d3-f0f6b1c46bd5"
        ],
        "package_ndc": [
          "60923-465-02"
        ],
        "nui": [
          "N0000191626",
          "M0025055",
          "N0000009533"
        ],
        "pharm_class_epc": [
          "Antisense Oligonucleotide [EPC]"
        ],
        "pharm_class_cs": [
          "Oligonucleotides, Antisense [CS]"
        ],
        "pharm_class_pe": [
          "Increased Protein Synthesis [PE]"
        ],
        "unii": [
          "033072U4MZ"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "VYONDYS 53",
          "active_ingredients": [
            {
              "name": "GOLODIRSEN",
              "strength": "100MG/2ML (50MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}