{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20170531",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "48616",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021549s027,207865s001lbl.pdf",
              "date": "20170601",
              "type": "Label"
            },
            {
              "id": "48635",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021549Orig1s027,207865Orig1s001ltr.pdf",
              "date": "20170602",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20130320",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37211",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s019lbl.pdf",
              "date": "20130326",
              "type": "Label"
            },
            {
              "id": "5719",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021549Orig1s019ltr.pdf",
              "date": "20130322",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20150828",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "5721",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021549Orig1s025ltr.pdf",
              "date": "20150901",
              "type": "Letter"
            },
            {
              "id": "15770",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021549s025lbl.pdf",
              "date": "20150903",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20100319",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "5718",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021549s017ltr.pdf",
              "date": "20100325",
              "type": "Letter"
            },
            {
              "id": "15767",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021549s017lbl.pdf",
              "date": "20100326",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20190925",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60115",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021549Orig1s031, 207865Orig1s004ltr.pdf",
              "date": "20190926",
              "type": "Letter"
            },
            {
              "id": "60125",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s031,207865s004lbl.pdf",
              "date": "20190926",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20130327",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5720",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021549Orig1s023,022023Orig1s010ltr.pdf",
              "date": "20130329",
              "type": "Letter"
            },
            {
              "id": "15768",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021549s023lbl.pdf",
              "date": "20130401",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20081118",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37210",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021549s015lbl.pdf",
              "date": "20081119",
              "type": "Label"
            },
            {
              "id": "28100",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021549s015ltr.pdf",
              "date": "20081121",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20120706",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37212",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021549s021lbl.pdf",
              "date": "20120710",
              "type": "Label"
            },
            {
              "id": "28101",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021549Orig1s021ltr.pdf",
              "date": "20120711",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20060609",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5716",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021549s011rev1.pdf",
              "date": "20060612",
              "type": "Letter"
            },
            {
              "id": "37208",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021549s011lbl.pdf",
              "date": "20060614",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20051028",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "37207",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021549s008lbl.pdf",
              "date": "20051101",
              "type": "Label"
            },
            {
              "id": "5714",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021549s008ltr.pdf",
              "date": "20051101",
              "type": "Letter"
            },
            {
              "id": "21731",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021549Orig1S008.pdf",
              "date": "20120302",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20041215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37205",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21549s004lbl.pdf",
              "date": "20041230",
              "type": "Label"
            },
            {
              "id": "5713",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21549s004ltr.pdf",
              "date": "20041230",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20040115",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5712",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21549slr002ltr.pdf",
              "date": "20040122",
              "type": "Letter"
            },
            {
              "id": "21730",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021549_S002_EMEND.pdf",
              "date": "20071119",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20150112",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20030326",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "37204",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21549_Emend_lbl.pdf",
              "date": "20030328",
              "type": "Label"
            },
            {
              "id": "42208",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-549_Emend.html",
              "date": "20030706",
              "type": "Review"
            },
            {
              "id": "28095",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21549ltr.pdf",
              "date": "20030328",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20140812",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "15769",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021549s024lbl.pdf",
              "date": "20140813",
              "type": "Label"
            },
            {
              "id": "28102",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021549Orig1s024,022023Orig1s011ltr.pdf",
              "date": "20140814",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20090202",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5717",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021549s016ltr.pdf",
              "date": "20090204",
              "type": "Letter"
            },
            {
              "id": "15766",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021549s016lbl.pdf",
              "date": "20090204",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20191114",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60842",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021549Orig1s030, 022023Orig1s019, 207865Orig1s003ltr.pdf",
              "date": "20191115",
              "type": "Letter"
            },
            {
              "id": "60853",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021549s030,207865s003lbl.pdf",
              "date": "20191115",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20090721",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "28099",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021549s014ltr.pdf",
              "date": "20090723",
              "type": "Letter"
            },
            {
              "id": "37209",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021549s014lbl.pdf",
              "date": "20090723",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20071115",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "15765",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021549s012lbl.pdf",
              "date": "20071119",
              "type": "Label"
            },
            {
              "id": "28098",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021549s012ltr.pdf",
              "date": "20071119",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20060630",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "73958",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/021549Orig1s010.pdf",
              "date": "20230406",
              "type": "Review"
            },
            {
              "id": "15764",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021549s010lbl.pdf",
              "date": "20060703",
              "type": "Label"
            },
            {
              "id": "28097",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021549s010LTR.pdf",
              "date": "20060713",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20050609",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5715",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021549s009ltr.pdf",
              "date": "20050614",
              "type": "Letter"
            },
            {
              "id": "15763",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021549s009lbl.pdf",
              "date": "20050614",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20041222",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "28096",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21549s007ltr.pdf",
              "date": "20041229",
              "type": "Letter"
            },
            {
              "id": "37206",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21549s007lbl.pdf",
              "date": "20041229",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA021549",
      "sponsor_name": "MSD",
      "openfda": {
        "application_number": [
          "NDA021549"
        ],
        "brand_name": [
          "EMEND"
        ],
        "generic_name": [
          "APREPITANT"
        ],
        "manufacturer_name": [
          "Merck Sharp & Dohme LLC"
        ],
        "product_ndc": [
          "0006-0461",
          "0006-0462",
          "0006-3862",
          "0006-0464",
          "0006-3066"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "APREPITANT"
        ],
        "rxcui": [
          "403810",
          "403811",
          "404465",
          "404466",
          "644088",
          "644278",
          "754508",
          "754509",
          "1729308",
          "1729311"
        ],
        "spl_id": [
          "428f7828-6d1c-438b-a17d-b4af0700c740"
        ],
        "spl_set_id": [
          "696f9e80-9cae-403b-de9e-078343ce4713"
        ],
        "package_ndc": [
          "0006-0461-02",
          "0006-0461-01",
          "0006-0461-06",
          "0006-0461-12",
          "0006-0462-01",
          "0006-0462-06",
          "0006-3862-03",
          "0006-3862-13",
          "0006-0464-01",
          "0006-0464-10",
          "0006-0464-05",
          "0006-3066-01",
          "0006-3066-03"
        ],
        "nui": [
          "N0000010262",
          "N0000175786",
          "N0000182141",
          "N0000185507",
          "N0000185506"
        ],
        "pharm_class_moa": [
          "Neurokinin 1 Antagonists [MoA]",
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "Cytochrome P450 2C9 Inducers [MoA]",
          "Cytochrome P450 3A4 Inducers [MoA]"
        ],
        "pharm_class_epc": [
          "Substance P/Neurokinin-1 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "1NF15YR6UY"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "EMEND",
          "active_ingredients": [
            {
              "name": "APREPITANT",
              "strength": "125MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "EMEND",
          "active_ingredients": [
            {
              "name": "APREPITANT",
              "strength": "40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "EMEND",
          "active_ingredients": [
            {
              "name": "APREPITANT",
              "strength": "80MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}