{
  "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": "1",
          "submission_status": "AP",
          "submission_status_date": "20150518",
          "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": "20140926",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "40093",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201923s000lbl.pdf",
              "date": "20140930",
              "type": "Label"
            },
            {
              "id": "22865",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/201923Orig1s000TOC.html",
              "date": "20160318",
              "type": "Review"
            },
            {
              "id": "32148",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201923Orig1s000ltr.pdf",
              "date": "20140929",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20250312",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "81562",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/201923Orig1s006ltr.pdf",
              "date": "20250314",
              "type": "Letter"
            },
            {
              "id": "81582",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/201923s006lbl.pdf",
              "date": "20250317",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20170308",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47514",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201923s002lbl.pdf",
              "date": "20170309",
              "type": "Label"
            },
            {
              "id": "47563",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201923Orig1s002ltr.pdf",
              "date": "20170314",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA201923",
      "sponsor_name": "ALIMERA SCIENCES INC",
      "openfda": {
        "application_number": [
          "NDA201923"
        ],
        "brand_name": [
          "ILUVIEN"
        ],
        "generic_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "manufacturer_name": [
          "ANI Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68611-190"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVITREAL"
        ],
        "substance_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "rxcui": [
          "1552351",
          "1552356"
        ],
        "spl_id": [
          "78b978f0-fc11-11f0-b558-0800200c9a66"
        ],
        "spl_set_id": [
          "4400e471-7402-11df-93f2-0800200c9a66"
        ],
        "package_ndc": [
          "68611-190-02"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "0CD5FD6S2M"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ILUVIEN",
          "active_ingredients": [
            {
              "name": "FLUOCINOLONE ACETONIDE",
              "strength": "0.19MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "IMPLANT",
          "route": "INTRAVITREAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}