{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20260220",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "85114",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220358Orig1s000ltr.pdf",
              "date": "20260224",
              "type": "Letter"
            },
            {
              "id": "85157",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220358Orig1s000lbl.pdf",
              "date": "20260225",
              "type": "Label"
            },
            {
              "id": "85313",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/220358Orig1s000TOC.html",
              "date": "20260310",
              "type": "Review"
            },
            {
              "id": "85314",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/220358Orig1s000TOC.html",
              "date": "20260310",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA220358",
      "sponsor_name": "VANDA PHARMS INC",
      "openfda": {
        "application_number": [
          "NDA220358"
        ],
        "brand_name": [
          "BYSANTI"
        ],
        "generic_name": [
          "MILSAPERIDONE"
        ],
        "manufacturer_name": [
          "Vanda Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "43068-701",
          "43068-908",
          "43068-702",
          "43068-704",
          "43068-706",
          "43068-910",
          "43068-708",
          "43068-911",
          "43068-710",
          "43068-712",
          "43068-713",
          "43068-714",
          "43068-715",
          "43068-912",
          "43068-913",
          "43068-914"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MILSAPERIDONE"
        ],
        "rxcui": [
          "2745770",
          "2745776",
          "2745778",
          "2745780",
          "2745782",
          "2745784",
          "2745786",
          "2745788",
          "2745790",
          "2745792",
          "2745794",
          "2745796",
          "2745798",
          "2745800",
          "2746018",
          "2746019",
          "2746020",
          "2746021",
          "2746022",
          "2746023"
        ],
        "spl_id": [
          "d49d59a7-1bab-44a6-9d19-4b5635a3f378"
        ],
        "spl_set_id": [
          "254a1c01-4a4c-4bdd-85d6-1f23f2e4e6f8"
        ],
        "package_ndc": [
          "43068-701-02",
          "43068-908-14",
          "43068-702-02",
          "43068-704-02",
          "43068-706-02",
          "43068-910-14",
          "43068-708-02",
          "43068-911-14",
          "43068-710-02",
          "43068-712-02",
          "43068-713-04",
          "43068-714-04",
          "43068-715-03",
          "43068-912-08",
          "43068-913-12",
          "43068-914-08"
        ],
        "unii": [
          "7SV1ZOG031"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "BYSANTI",
          "active_ingredients": [
            {
              "name": "MILSAPERIDONE",
              "strength": "4MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "BYSANTI",
          "active_ingredients": [
            {
              "name": "MILSAPERIDONE",
              "strength": "1MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "006",
          "reference_drug": "Yes",
          "brand_name": "BYSANTI",
          "active_ingredients": [
            {
              "name": "MILSAPERIDONE",
              "strength": "10MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "BYSANTI",
          "active_ingredients": [
            {
              "name": "MILSAPERIDONE",
              "strength": "6MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "BYSANTI",
          "active_ingredients": [
            {
              "name": "MILSAPERIDONE",
              "strength": "2MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "007",
          "reference_drug": "Yes",
          "brand_name": "BYSANTI",
          "active_ingredients": [
            {
              "name": "MILSAPERIDONE",
              "strength": "12MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "BYSANTI",
          "active_ingredients": [
            {
              "name": "MILSAPERIDONE",
              "strength": "8MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}