{
  "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": "18",
          "submission_status": "AP",
          "submission_status_date": "20200528",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "63351",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022395s018lbl.pdf",
              "date": "20200529",
              "type": "Label"
            },
            {
              "id": "63355",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022395Orig1s018ltr.pdf",
              "date": "20200601",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20091116",
          "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": "44746",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022395s000Sumr.pdf",
              "date": "20100629",
              "type": "Summary Review"
            },
            {
              "id": "17309",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022395lbl.pdf",
              "date": "20091117",
              "type": "Label"
            },
            {
              "id": "22010",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022395_qutenza_toc.html",
              "date": "20100629",
              "type": "Review"
            },
            {
              "id": "29674",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022395s000ltr.pdf",
              "date": "20091119",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20240731",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "79268",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022395Orig1s024ltr.pdf",
              "date": "20240802",
              "type": "Letter"
            },
            {
              "id": "79284",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022395s024lbl.pdf",
              "date": "20240802",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20160224",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20121214",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20210805",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68303",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022395s020lbl.pdf",
              "date": "20210806",
              "type": "Label"
            },
            {
              "id": "68312",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022395Orig1s020ltr.pdf",
              "date": "20210806",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20200717",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "63973",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022395Orig1s019ltr.pdf",
              "date": "20200720",
              "type": "Letter"
            },
            {
              "id": "64059",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022395s019lbl.pdf",
              "date": "20200723",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20230217",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "73557",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022395Orig1s023ltr.pdf",
              "date": "20230217",
              "type": "Letter"
            },
            {
              "id": "73575",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022395s023lbl.pdf",
              "date": "20230221",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20150521",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20220811",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "71790",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022395Orig1s021ltr.pdf",
              "date": "20220812",
              "type": "Letter"
            },
            {
              "id": "71802",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022395s021lbl.pdf",
              "date": "20220815",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA022395",
      "sponsor_name": "AVERITAS",
      "openfda": {
        "application_number": [
          "NDA022395"
        ],
        "brand_name": [
          "QUTENZA"
        ],
        "generic_name": [
          "CAPSAICIN"
        ],
        "manufacturer_name": [
          "Averitas Pharma Inc"
        ],
        "product_ndc": [
          "72512-928",
          "72512-929",
          "72512-930"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "1039679",
          "1039681"
        ],
        "spl_id": [
          "d641ea90-cf4f-46b5-b309-1f06d4352086"
        ],
        "spl_set_id": [
          "3ffbbcb0-ad93-4f15-bb38-5da76a71c735"
        ],
        "package_ndc": [
          "72512-928-01",
          "72512-920-00",
          "72512-929-01",
          "72512-920-01",
          "72512-930-01",
          "72512-920-02"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "QUTENZA",
          "active_ingredients": [
            {
              "name": "CAPSAICIN",
              "strength": "8%"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "PATCH",
          "route": "TOPICAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}