{
  "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": "3",
          "submission_status": "AP",
          "submission_status_date": "20220429",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "70871",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211964s003lbl.pdf",
              "date": "20220502",
              "type": "Label"
            },
            {
              "id": "70955",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211964Orig1s003ltr.pdf",
              "date": "20220503",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20250123",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "81039",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211964s013lbl.pdf",
              "date": "20250206",
              "type": "Label"
            },
            {
              "id": "81040",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211964s013lbl.pdf#page=21",
              "date": "20250206",
              "type": "Medication Guide"
            },
            {
              "id": "81093",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211964Orig1s013ltr.pdf",
              "date": "20250206",
              "type": "Letter"
            },
            {
              "id": "81094",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211964Orig1s013ltr.pdf",
              "date": "20250206",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20210402",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "66987",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211964s000lbl.pdf",
              "date": "20210402",
              "type": "Label"
            },
            {
              "id": "67616",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211964Orig1s000ltr.pdf",
              "date": "20210405",
              "type": "Letter"
            },
            {
              "id": "68096",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211964Orig1s000TOC.html",
              "date": "20210503",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA211964",
      "sponsor_name": "SUPERNUS PHARMS",
      "openfda": {
        "application_number": [
          "NDA211964"
        ],
        "brand_name": [
          "QELBREE"
        ],
        "generic_name": [
          "VILOXAZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Supernus Pharmaceuticals, Inc"
        ],
        "product_ndc": [
          "17772-131",
          "17772-132",
          "17772-133"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VILOXAZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "2536548",
          "2536554",
          "2536750",
          "2536752",
          "2536756",
          "2536758"
        ],
        "spl_id": [
          "453c9f61-1902-44ab-e063-6394a90ab639"
        ],
        "spl_set_id": [
          "aedf408d-0f84-418d-9416-7c39ddb0d29a"
        ],
        "package_ndc": [
          "17772-131-30",
          "17772-131-60",
          "17772-131-90",
          "17772-131-01",
          "17772-131-07",
          "17772-132-30",
          "17772-132-60",
          "17772-132-90",
          "17772-132-01",
          "17772-132-07",
          "17772-133-30",
          "17772-133-60",
          "17772-133-90",
          "17772-133-01",
          "17772-133-07"
        ],
        "unii": [
          "OQW30I1332"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "QELBREE",
          "active_ingredients": [
            {
              "name": "VILOXAZINE HYDROCHLORIDE",
              "strength": "EQ 200MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "QELBREE",
          "active_ingredients": [
            {
              "name": "VILOXAZINE HYDROCHLORIDE",
              "strength": "EQ 100MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "QELBREE",
          "active_ingredients": [
            {
              "name": "VILOXAZINE HYDROCHLORIDE",
              "strength": "EQ 150MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}