{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20230505",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "74185",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204251s012lbl.pdf",
              "date": "20230508",
              "type": "Label"
            },
            {
              "id": "74186",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204251Orig1s012ltr.pdf",
              "date": "20230508",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20130419",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 4",
          "submission_class_code_description": "Type 4 - New Combination",
          "application_docs": [
            {
              "id": "19537",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204251s000lbl.pdf",
              "date": "20130423",
              "type": "Label"
            },
            {
              "id": "22948",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204251_simbrinza_toc.html",
              "date": "20130926",
              "type": "Review"
            },
            {
              "id": "24463",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204251Orig1s000SumR.pdf",
              "date": "20130926",
              "type": "Summary Review"
            },
            {
              "id": "32531",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204251Orig1s000ltr.pdf",
              "date": "20130424",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20160609",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20160115",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20160120",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20151105",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "19538",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204251s006lbl.pdf",
              "date": "20151112",
              "type": "Label"
            },
            {
              "id": "32532",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204251Orig1s006ltr.pdf",
              "date": "20151109",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA204251",
      "sponsor_name": "ALCON LABS INC",
      "openfda": {
        "application_number": [
          "NDA204251"
        ],
        "brand_name": [
          "SIMBRINZA"
        ],
        "generic_name": [
          "BRINZOLAMIDE/BRIMONIDINE TARTRATE"
        ],
        "manufacturer_name": [
          "Alcon Laboratories, Inc."
        ],
        "product_ndc": [
          "0065-4147"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "BRIMONIDINE TARTRATE",
          "BRINZOLAMIDE"
        ],
        "rxcui": [
          "1421451",
          "1421456"
        ],
        "spl_id": [
          "889225d1-6257-4b32-b9cc-5f9c459c994a"
        ],
        "spl_set_id": [
          "a49c157e-6310-0011-7b7f-e26fc1820d59"
        ],
        "package_ndc": [
          "0065-4147-27",
          "0065-4147-25"
        ],
        "nui": [
          "N0000175517",
          "N0000000235"
        ],
        "pharm_class_epc": [
          "Carbonic Anhydrase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Carbonic Anhydrase Inhibitors [MoA]"
        ],
        "unii": [
          "4S9CL2DY2H",
          "9451Z89515"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "SIMBRINZA",
          "active_ingredients": [
            {
              "name": "BRIMONIDINE TARTRATE",
              "strength": "0.2%"
            },
            {
              "name": "BRINZOLAMIDE",
              "strength": "1%"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SUSPENSION/DROPS",
          "route": "OPHTHALMIC",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}