{
  "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": "9",
          "submission_status": "AP",
          "submission_status_date": "20230628",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "74653",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211230Orig1s009ltr.pdf",
              "date": "20230629",
              "type": "Letter"
            },
            {
              "id": "74664",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211230s009lbl.pdf",
              "date": "20230629",
              "type": "Label"
            },
            {
              "id": "74665",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211230s009lbl.pdf#page=23",
              "date": "20230629",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20221201",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "72763",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211230Orig1s007ltr.pdf",
              "date": "20221202",
              "type": "Letter"
            },
            {
              "id": "72773",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211230Orig1s007lbl.pdf",
              "date": "20221205",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20190320",
          "submission_public_notes": "FR Notice on DEA Scheduling; Date of Approval  June 17, 2019",
          "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": "58048",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230_Orig1Orig2s000lbl.pdf",
              "date": "20200320",
              "type": "Label"
            },
            {
              "id": "58052",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211230Orig1s000, Orig2s000ltr.pdf",
              "date": "20200320",
              "type": "Letter"
            },
            {
              "id": "58466",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211230Orig1Orig2s000TOC.html",
              "date": "20190429",
              "type": "Review"
            },
            {
              "id": "68944",
              "url": "https://www.federalregister.gov/documents/2019/06/17/2019-12723/schedules-of-controlled-substances-placement-of-solriamfetol-in-schedule-iv",
              "date": "20211008",
              "type": "Federal Register Notice"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20191007",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60273",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s001lbl.pdf",
              "date": "20191007",
              "type": "Label"
            },
            {
              "id": "60470",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211230Orig1s001ltr.pdf",
              "date": "20191009",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20190320",
          "submission_public_notes": "FR Notice on DEA Scheduling; Date of Approval  June 17, 2019",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "58049",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230_Orig1Orig2s000lbl.pdf",
              "date": "20200320",
              "type": "Label"
            },
            {
              "id": "58051",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211230Orig1s000, Orig2s000ltr.pdf",
              "date": "20200320",
              "type": "Letter"
            },
            {
              "id": "58467",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211230Orig1Orig2s000TOC.html",
              "date": "20190429",
              "type": "Review"
            },
            {
              "id": "68943",
              "url": "https://www.federalregister.gov/documents/2019/06/17/2019-12723/schedules-of-controlled-substances-placement-of-solriamfetol-in-schedule-iv",
              "date": "20211008",
              "type": "Federal Register Notice"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20211020",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "69063",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211230Orig1s004ltr.pdf",
              "date": "20211021",
              "type": "Letter"
            },
            {
              "id": "69136",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211230s004lbl.pdf",
              "date": "20211027",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA211230",
      "sponsor_name": "AXSOME MALTA",
      "openfda": {
        "application_number": [
          "NDA211230"
        ],
        "brand_name": [
          "SUNOSI"
        ],
        "generic_name": [
          "SOLRIAMFETOL"
        ],
        "manufacturer_name": [
          "Axsome Therapeutics, Inc."
        ],
        "product_ndc": [
          "81968-350",
          "81968-351"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SOLRIAMFETOL"
        ],
        "rxcui": [
          "2121756",
          "2121758",
          "2121764",
          "2173841"
        ],
        "spl_id": [
          "f0a0a507-33cd-4ab1-b438-12996fae6ae1"
        ],
        "spl_set_id": [
          "362f206b-73e7-4009-8c34-5a9df55679ab"
        ],
        "package_ndc": [
          "81968-350-01",
          "81968-350-07",
          "81968-350-10",
          "81968-351-01",
          "81968-351-07",
          "81968-351-10"
        ],
        "nui": [
          "N0000194049",
          "N0000000114",
          "N0000000102"
        ],
        "pharm_class_epc": [
          "Dopamine and Norepinephrine Reuptake Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Dopamine Uptake Inhibitors [MoA]",
          "Norepinephrine Uptake Inhibitors [MoA]"
        ],
        "unii": [
          "939U7C91AI"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "SUNOSI",
          "active_ingredients": [
            {
              "name": "SOLRIAMFETOL HYDROCHLORIDE",
              "strength": "EQ 75MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "SUNOSI",
          "active_ingredients": [
            {
              "name": "SOLRIAMFETOL HYDROCHLORIDE",
              "strength": "EQ 150MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}