{
  "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": "19",
          "submission_status": "AP",
          "submission_status_date": "20130823",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20120113",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "6357",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf",
              "date": "20120119",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20170207",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47134",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf",
              "date": "20170207",
              "type": "Label"
            },
            {
              "id": "47154",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021875Orig1s023ltr.pdf",
              "date": "20170209",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20101021",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16500",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf",
              "date": "20101025",
              "type": "Label"
            },
            {
              "id": "28754",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf",
              "date": "20101025",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20150416",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6358",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021875Orig1s021ltr.pdf",
              "date": "20150417",
              "type": "Letter"
            },
            {
              "id": "16501",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021875s021lbledt.pdf",
              "date": "20150416",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20101021",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16499",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf",
              "date": "20101025",
              "type": "Label"
            },
            {
              "id": "28753",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf",
              "date": "20101025",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20090326",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "28752",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021875s006ltr.pdf",
              "date": "20090401",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20130405",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20120113",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "28755",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020717s040,s041,021875s016,s017ltr.pdf",
              "date": "20120119",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20150209",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20130628",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6356",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021875Orig1s012ltr.pdf",
              "date": "20130702",
              "type": "Letter"
            },
            {
              "id": "37802",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021875s012lbl.pdf",
              "date": "20130715",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20070615",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "21852",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021875_nuvigil_toc.html",
              "date": "20090305",
              "type": "Review"
            },
            {
              "id": "23307",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015MedGuide.pdf",
              "date": "20130726",
              "type": "Medication Guide"
            },
            {
              "id": "28750",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021875s000ltr.pdf",
              "date": "20070705",
              "type": "Letter"
            },
            {
              "id": "37801",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021875lbl.pdf",
              "date": "20070627",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20101021",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16498",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf",
              "date": "20101025",
              "type": "Label"
            },
            {
              "id": "28751",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021875s005,s008,s015ltr.pdf",
              "date": "20101025",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021875",
      "sponsor_name": "NUVO PHARMS",
      "openfda": {
        "application_number": [
          "NDA021875"
        ],
        "brand_name": [
          "NUVIGIL",
          "ARMODAFINIL"
        ],
        "generic_name": [
          "ARMODAFINIL"
        ],
        "manufacturer_name": [
          "Cephalon, LLC",
          "Teva Pharmaceuticals USA, Inc.",
          "Sandoz Inc",
          "Apotex Corp."
        ],
        "product_ndc": [
          "63459-215",
          "63459-205",
          "63459-220",
          "63459-225",
          "0093-3090",
          "0093-3092",
          "0093-3093",
          "0093-3094",
          "0781-8029",
          "0781-8037",
          "0781-8045",
          "0781-8053",
          "60505-4846",
          "60505-4847",
          "60505-4849",
          "60505-4850"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ARMODAFINIL"
        ],
        "rxcui": [
          "724859",
          "724861",
          "724863",
          "805659",
          "805661",
          "805663",
          "861960",
          "861962"
        ],
        "spl_id": [
          "a70488d7-57ea-446e-89c2-87b0ecc90023",
          "ca66f83d-4d17-4516-9163-abdb19872555",
          "dea0ad34-a35f-42ba-a6b6-dea58a16868f",
          "ab761afd-b864-a5f9-e204-952c98103e63"
        ],
        "spl_set_id": [
          "d878aed0-ddbf-8fa1-abf7-d3e480260845",
          "b3cac300-c3d2-4189-a410-2aaf3773c090",
          "a3341ec8-1ad4-49e2-922b-13d1b30c8c1d",
          "a69631d0-1263-769e-b232-4ab9160e0fa3"
        ],
        "package_ndc": [
          "63459-205-30",
          "63459-215-07",
          "63459-215-35",
          "63459-215-30",
          "63459-220-07",
          "63459-220-35",
          "63459-220-30",
          "63459-225-07",
          "63459-225-35",
          "63459-225-30",
          "0093-3090-56",
          "0093-3092-56",
          "0093-3093-56",
          "0093-3094-56",
          "0781-8029-31",
          "0781-8037-31",
          "0781-8045-31",
          "0781-8053-31",
          "60505-4846-3",
          "60505-4847-3",
          "60505-4849-3",
          "60505-4850-3"
        ],
        "unii": [
          "V63XWA605I"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "NUVIGIL",
          "active_ingredients": [
            {
              "name": "ARMODAFINIL",
              "strength": "150MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "NUVIGIL",
          "active_ingredients": [
            {
              "name": "ARMODAFINIL",
              "strength": "50MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "NUVIGIL",
          "active_ingredients": [
            {
              "name": "ARMODAFINIL",
              "strength": "250MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "NUVIGIL",
          "active_ingredients": [
            {
              "name": "ARMODAFINIL",
              "strength": "100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "NUVIGIL",
          "active_ingredients": [
            {
              "name": "ARMODAFINIL",
              "strength": "200MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}