{
  "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": "1",
          "submission_status": "AP",
          "submission_status_date": "20251222",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84545",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219847Orig1s001lbl.pdf",
              "date": "20251223",
              "type": "Label"
            },
            {
              "id": "84589",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219847Orig1s001ltr.pdf",
              "date": "20251229",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20250616",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "82585",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219847s000lbl.pdf",
              "date": "20250616",
              "type": "Label"
            },
            {
              "id": "82586",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219847s000lbl.pdf#page=37",
              "date": "20250617",
              "type": "Medication Guide"
            },
            {
              "id": "82590",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219847Orig1s000ltr.pdf",
              "date": "20250617",
              "type": "Letter"
            },
            {
              "id": "83303",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219847Orig1s000TOC.html",
              "date": "20250908",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA219847",
      "sponsor_name": "AZURITY",
      "openfda": {
        "application_number": [
          "NDA219847"
        ],
        "brand_name": [
          "ARYNTA"
        ],
        "generic_name": [
          "LISDEXAMFETAMINE DIMESYLATE ORAL"
        ],
        "manufacturer_name": [
          "Azurity Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "24338-019",
          "24338-103",
          "24338-160",
          "24338-109",
          "24338-162"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LISDEXAMFETAMINE DIMESYLATE"
        ],
        "rxcui": [
          "2726048",
          "2726055"
        ],
        "spl_id": [
          "ac355447-df74-4bb1-b0b6-1869a4846309"
        ],
        "spl_set_id": [
          "71cdfc97-96af-4378-a44a-6d5d77e7d6b7"
        ],
        "package_ndc": [
          "24338-019-01",
          "24338-103-01",
          "24338-160-01",
          "24338-109-01",
          "24338-162-01"
        ],
        "unii": [
          "SJT761GEGS"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ARYNTA",
          "active_ingredients": [
            {
              "name": "LISDEXAMFETAMINE DIMESYLATE",
              "strength": "10MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}