{
  "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": "8",
          "submission_status": "AP",
          "submission_status_date": "20201022",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "65016",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205435s013,205436s008lbl.pdf",
              "date": "20201023",
              "type": "Label"
            },
            {
              "id": "65029",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205435Orig1s013,205436Orig1s008ltr.pdf",
              "date": "20201027",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20190909",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "59959",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205435Orig1s011,%20205436Orig1s006ltr.pdf",
              "date": "20190911",
              "type": "Letter"
            },
            {
              "id": "59961",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205435s011,205436s006lbl.pdf",
              "date": "20190910",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20170812",
          "submission_public_notes": "Please see <a href=\"https://www.fda.gov/STIC/\">www.fda.gov/STIC</a> for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49431",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205435s008,205436s004lbl.pdf",
              "date": "20170816",
              "type": "Label"
            },
            {
              "id": "49476",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205435Orig1s008,205436Orig1s004ltr.pdf",
              "date": "20170821",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20161028",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "45736",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205435Orig1s003,205436Orig1s002ltr.pdf",
              "date": "20161031",
              "type": "Letter"
            },
            {
              "id": "45803",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205435s003,205436s002lbl.pdf",
              "date": "20161104",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20260227",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "85207",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/205435Orig1s019, 205436Orig1s015ltr.pdf",
              "date": "20260303",
              "type": "Letter"
            },
            {
              "id": "85276",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/205436s015lbl.pdf",
              "date": "20260306",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20250404",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "81828",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/205435s016,205436s013lbl.pdf",
              "date": "20250407",
              "type": "Label"
            },
            {
              "id": "81885",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/205435Orig1s016, 205436Orig1s013ltr.pdf",
              "date": "20250408",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20211117",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69347",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205435Orig1s014, 205436Orig1s009ltr.pdf",
              "date": "20211118",
              "type": "Letter"
            },
            {
              "id": "69355",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205435s014,205435s009lbl.pdf",
              "date": "20211118",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20200619",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "63661",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205435Orig1s012; 205436Orig1s007ltr.pdf",
              "date": "20200622",
              "type": "Letter"
            },
            {
              "id": "63674",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205435s012,205436s007lbl.pdf",
              "date": "20200623",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20190306",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "57933",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205435Orig1s010,%20205436Orig1s005ltr.pdf",
              "date": "20190308",
              "type": "Letter"
            },
            {
              "id": "57979",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205436s005lbl.pdf",
              "date": "20190313",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20170812",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49432",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205435s007,205436s003lbl.pdf",
              "date": "20170816",
              "type": "Label"
            },
            {
              "id": "49478",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205435Orig1s007,205436Orig1s003ltr.pdf",
              "date": "20170821",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20150304",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10450",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205435Orig1s001,205436Orig1s001ltr.pdf",
              "date": "20150306",
              "type": "Letter"
            },
            {
              "id": "19647",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/0205435s001,0205436s001lbl.pdf",
              "date": "20150309",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20140620",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "40470",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205436s000lbl.pdf",
              "date": "20140623",
              "type": "Label"
            },
            {
              "id": "43489",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205436Orig1s000TOC.html",
              "date": "20141010",
              "type": "Review"
            },
            {
              "id": "10449",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205436Orig1s000ltr.pdf",
              "date": "20140623",
              "type": "Letter"
            },
            {
              "id": "24495",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205436Orig1s000SumR.pdf",
              "date": "20141010",
              "type": "Summary Review"
            }
          ]
        }
      ],
      "application_number": "NDA205436",
      "sponsor_name": "CUBIST PHARMS LLC",
      "openfda": {
        "application_number": [
          "NDA205436"
        ],
        "brand_name": [
          "SIVEXTRO"
        ],
        "generic_name": [
          "TEDIZOLID PHOSPHATE"
        ],
        "manufacturer_name": [
          "Merck Sharp & Dohme LLC"
        ],
        "product_ndc": [
          "67919-040",
          "67919-041"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "TEDIZOLID PHOSPHATE"
        ],
        "rxcui": [
          "1540862",
          "1540868",
          "1540886",
          "1540890"
        ],
        "spl_id": [
          "340a4655-ccf2-4c0f-a305-7576c06f4518"
        ],
        "spl_set_id": [
          "75672079-589f-451a-bdbf-eaebcfcc80a9"
        ],
        "package_ndc": [
          "67919-041-04",
          "67919-041-05",
          "67919-040-02"
        ],
        "unii": [
          "O7DRJ6R4DW"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "SIVEXTRO",
          "active_ingredients": [
            {
              "name": "TEDIZOLID PHOSPHATE",
              "strength": "200MG/VIAL"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "POWDER",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}