{
  "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": "20250124",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "80987",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208259s012lbl.pdf",
              "date": "20250205",
              "type": "Label"
            },
            {
              "id": "81086",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208259Orig1s012ltr.pdf",
              "date": "20250206",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20200601",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20190312",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 4/5",
          "submission_class_code_description": "New Combination and New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "57989",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208259s000lbl.pdf",
              "date": "20190313",
              "type": "Label"
            },
            {
              "id": "57996",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208259Orig1s000ltr.pdf",
              "date": "20190314",
              "type": "Letter"
            },
            {
              "id": "61004",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/208259Orig1s000TOC.html",
              "date": "20191120",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20200601",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "63401",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208259s006lbl.pdf",
              "date": "20200602",
              "type": "Label"
            },
            {
              "id": "63403",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208259Orig1s006ltr.pdf",
              "date": "20200602",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA208259",
      "sponsor_name": "ALCON LABS INC",
      "openfda": {
        "application_number": [
          "NDA208259"
        ],
        "brand_name": [
          "ROCKLATAN"
        ],
        "generic_name": [
          "NETARSUDIL AND LATANOPROST OPHTHALMIC SOLUTION, 0.02%/0.005%"
        ],
        "manufacturer_name": [
          "Alcon Laboratories, Inc."
        ],
        "product_ndc": [
          "70727-529"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC",
          "TOPICAL"
        ],
        "substance_name": [
          "LATANOPROST",
          "NETARSUDIL MESYLATE"
        ],
        "rxcui": [
          "2119701",
          "2119706"
        ],
        "spl_id": [
          "37be9b45-067b-4ed3-a455-92a4be4b1a25"
        ],
        "spl_set_id": [
          "b1d71f41-be06-4a08-94d4-e352198f09c2"
        ],
        "package_ndc": [
          "70727-529-25",
          "70727-529-99"
        ],
        "nui": [
          "N0000175454",
          "M0017805"
        ],
        "pharm_class_epc": [
          "Prostaglandin Analog [EPC]"
        ],
        "pharm_class_cs": [
          "Prostaglandins [CS]"
        ],
        "unii": [
          "6Z5B6HVF6O",
          "VL756B1K0U"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ROCKLATAN",
          "active_ingredients": [
            {
              "name": "LATANOPROST",
              "strength": "0.005%"
            },
            {
              "name": "NETARSUDIL DIMESYLATE",
              "strength": "EQ 0.02% BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION/DROPS",
          "route": "OPHTHALMIC",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}