{
  "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": "17",
          "submission_status": "AP",
          "submission_status_date": "20161222",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20191120",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "61007",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050814Orig1s023ltr.pdf",
              "date": "20191121",
              "type": "Letter"
            },
            {
              "id": "61012",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050814s023lbl.pdf",
              "date": "20191121",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20150112",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20190211",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "57504",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050814s021lbl.pdf",
              "date": "20190212",
              "type": "Label"
            },
            {
              "id": "57610",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050814Orig1s021ltr.pdf",
              "date": "20190214",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20120924",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "30604",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050814Orig1s007ltr.pdf",
              "date": "20120926",
              "type": "Letter"
            },
            {
              "id": "39382",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050814s007lbl.pdf",
              "date": "20120925",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20140519",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20100222",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "39381",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050814lbl.pdf",
              "date": "20100303",
              "type": "Label"
            },
            {
              "id": "44788",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050814Orig1s000SumR.pdf",
              "date": "20110304",
              "type": "Summary Review"
            },
            {
              "id": "22250",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050814s000_cayston_toc.html",
              "date": "20110304",
              "type": "Review"
            },
            {
              "id": "30603",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050814s000ltr.pdf",
              "date": "20100226",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20100820",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "8335",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050814s001ltr.pdf",
              "date": "20100825",
              "type": "Letter"
            },
            {
              "id": "22251",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050814Orig1s001.pdf",
              "date": "20111209",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20151228",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "8336",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050814Orig1s016ltr.pdf",
              "date": "20151230",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20141110",
          "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": "20140709",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20150209",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA050814",
      "sponsor_name": "GILEAD",
      "openfda": {
        "application_number": [
          "NDA050814"
        ],
        "brand_name": [
          "CAYSTON"
        ],
        "generic_name": [
          "AZTREONAM"
        ],
        "manufacturer_name": [
          "Gilead Sciences, Inc."
        ],
        "product_ndc": [
          "61958-0901"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "901610",
          "901614"
        ],
        "spl_id": [
          "1485e37e-2b42-42bf-abb3-dd1241b02449"
        ],
        "spl_set_id": [
          "67300ca3-8c53-4ce4-8e86-2c03be1f9b8a"
        ],
        "package_ndc": [
          "61958-0901-1"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "CAYSTON",
          "active_ingredients": [
            {
              "name": "AZTREONAM",
              "strength": "75MG/VIAL"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "FOR SOLUTION",
          "route": "INHALATION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}