{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20190329",
          "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": "58191",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/0202408s000lbl.pdf",
              "date": "20190402",
              "type": "Label"
            },
            {
              "id": "58202",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202408Orig1s000ltr.pdf",
              "date": "20190404",
              "type": "Letter"
            },
            {
              "id": "59320",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/202408Orig1s000TOC.html",
              "date": "20190712",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20210716",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "68111",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202408Orig1s001ltr.pdf",
              "date": "20210719",
              "type": "Letter"
            },
            {
              "id": "68131",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202408s001lbl.pdf",
              "date": "20210720",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA202408",
      "sponsor_name": "FERA PHARMS LLC",
      "openfda": {
        "application_number": [
          "NDA202408"
        ],
        "brand_name": [
          "AVACLYR"
        ],
        "generic_name": [
          "ACYCLOVIR"
        ],
        "manufacturer_name": [
          "Fera Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "48102-028"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "ACYCLOVIR"
        ],
        "rxcui": [
          "199413",
          "2734142"
        ],
        "spl_id": [
          "8b20bece-92d7-4715-aad0-6eddba900c2c"
        ],
        "spl_set_id": [
          "3ce26231-bc40-48b0-85e5-2e7622f334d7"
        ],
        "package_ndc": [
          "48102-028-35"
        ],
        "nui": [
          "N0000020060",
          "N0000180187",
          "N0000180188",
          "N0000175468",
          "N0000175459"
        ],
        "pharm_class_moa": [
          "DNA Polymerase Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]",
          "Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]",
          "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"
        ],
        "unii": [
          "X4HES1O11F"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "AVACLYR",
          "active_ingredients": [
            {
              "name": "ACYCLOVIR",
              "strength": "3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "OINTMENT",
          "route": "OPHTHALMIC",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}