{
  "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": "2026-07-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "19780612",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "19780808",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20150223",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "19991018",
          "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": "19720928",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "19970502",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20041110",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "521",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16968s022ltr.pdf",
              "date": "20041116",
              "type": "Letter"
            },
            {
              "id": "33211",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16968s022lbl.pdf",
              "date": "20041116",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "19960626",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20021125",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "520",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16968slr020ltr.pdf",
              "date": "20021125",
              "type": "Letter"
            },
            {
              "id": "10944",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16968slr020_Miostat_lbl.pdf",
              "date": "20021125",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "19891214",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "19840813",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "19830516",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "19800424",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20160121",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10945",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016968s029lbl.pdf",
              "date": "20160126",
              "type": "Label"
            },
            {
              "id": "13063",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016968Orig1s029ltr.pdf",
              "date": "20160122",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "19780612",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20011218",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "19990415",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "19970114",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "19950818",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "19831206",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "19800424",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "NDA016968",
      "sponsor_name": "ALCON",
      "openfda": {
        "application_number": [
          "NDA016968"
        ],
        "brand_name": [
          "MIOSTAT"
        ],
        "generic_name": [
          "CARBACHOL"
        ],
        "manufacturer_name": [
          "Alcon Laboratories, Inc."
        ],
        "product_ndc": [
          "0065-0023"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "CARBACHOL"
        ],
        "rxcui": [
          "308966",
          "991606"
        ],
        "spl_id": [
          "a76a34d0-2e07-408d-a8c8-d00f2715cad7"
        ],
        "spl_set_id": [
          "f28d7a56-e079-4a8b-ad81-9a97c780de67"
        ],
        "package_ndc": [
          "0065-0023-15"
        ],
        "unii": [
          "8Y164V895Y"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "MIOSTAT",
          "active_ingredients": [
            {
              "name": "CARBACHOL",
              "strength": "0.01%"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAOCULAR",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}