{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20160510",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "47165",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208081Orig1s000TOC.html",
              "date": "20170210",
              "type": "Review"
            },
            {
              "id": "10643",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208081Orig1s000ltr.pdf",
              "date": "20160516",
              "type": "Letter"
            },
            {
              "id": "19984",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208081s000lbl.pdf",
              "date": "20160511",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20170906",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49683",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208081s002lbl.pdf",
              "date": "20170907",
              "type": "Label"
            },
            {
              "id": "49702",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208081Orig1s002ltr.pdf",
              "date": "20170908",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20241004",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "79824",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208081Orig1s028ltr.pdf",
              "date": "20241007",
              "type": "Letter"
            },
            {
              "id": "79830",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208081s028lbl.pdf",
              "date": "20241007",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20240311",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "77859",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208081Orig1s026ltr.pdf",
              "date": "20240318",
              "type": "Letter"
            },
            {
              "id": "77868",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208081Orig1s026lbl.pdf",
              "date": "20240319",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "40",
          "submission_status": "AP",
          "submission_status_date": "20260909",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "87176",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208081Orig1s040lbl.pdf",
              "date": "20260911",
              "type": "Label"
            },
            {
              "id": "87177",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208081Orig1s040ltr.pdf",
              "date": "20260910",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20210525",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "67599",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208081Orig1s011ltr.pdf",
              "date": "20210526",
              "type": "Letter"
            },
            {
              "id": "67605",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208081s011lbl.pdf",
              "date": "20210527",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA208081",
      "sponsor_name": "BIOFRONTERA",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "AMELUZ",
          "active_ingredients": [
            {
              "name": "AMINOLEVULINIC ACID HYDROCHLORIDE",
              "strength": "10%"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "GEL",
          "route": "TOPICAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}