{
  "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": "20160225",
          "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": "20111220",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "15781",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021565s006lbl.pdf",
              "date": "20111223",
              "type": "Label"
            },
            {
              "id": "28120",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021565s006ltr.pdf",
              "date": "20111222",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20031016",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "42211",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-565_Elestat.html",
              "date": "20031231",
              "type": "Review"
            },
            {
              "id": "5740",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21565ltr.pdf",
              "date": "20031014",
              "type": "Letter"
            },
            {
              "id": "15780",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21565_elestat_lbl.pdf",
              "date": "20031017",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20130617",
          "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": "20050815",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "37228",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021565s005lbl.pdf",
              "date": "20050816",
              "type": "Label"
            },
            {
              "id": "28119",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021565s005ltr.pdf",
              "date": "20050819",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021565",
      "sponsor_name": "ALLERGAN",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ELESTAT",
          "active_ingredients": [
            {
              "name": "EPINASTINE HYDROCHLORIDE",
              "strength": "0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION/DROPS",
          "route": "OPHTHALMIC",
          "marketing_status": "Discontinued",
          "te_code": "AT"
        }
      ]
    }
  ]
}