{
  "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": "2026-07-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20181001",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "55784",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209521Orig1s000ltr.pdf",
              "date": "20181001",
              "type": "Letter"
            },
            {
              "id": "55785",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209521s000lbl.pdf",
              "date": "20181002",
              "type": "Label"
            },
            {
              "id": "56012",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209521Orig1s000TOC.html",
              "date": "20181018",
              "type": "Review"
            },
            {
              "id": "63265",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/355_209521 sarecycline multidisciplinary review_1.pdf",
              "date": "19000101",
              "type": "Pediatric Other"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20230330",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "73914",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209521Orig1s015,s016ltr.pdf",
              "date": "20230331",
              "type": "Letter"
            },
            {
              "id": "73918",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209521s015s016lbl.pdf",
              "date": "20230331",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20200601",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "63402",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209521s007lbl.pdf",
              "date": "20200602",
              "type": "Label"
            },
            {
              "id": "63404",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209521Orig1s007ltr.pdf",
              "date": "20200602",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20190409",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "58268",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209521s001lbl.pdf",
              "date": "20190410",
              "type": "Label"
            },
            {
              "id": "58275",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209521Orig1s001ltr.pdf",
              "date": "20190410",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20230330",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "73913",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209521Orig1s015,s016ltr.pdf",
              "date": "20230331",
              "type": "Letter"
            },
            {
              "id": "73917",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209521s015s016lbl.pdf",
              "date": "20230331",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA209521",
      "sponsor_name": "ALMIRALL",
      "openfda": {
        "application_number": [
          "NDA209521"
        ],
        "brand_name": [
          "SEYSARA"
        ],
        "generic_name": [
          "SARECYCLINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Almirall, LLC"
        ],
        "product_ndc": [
          "16110-245",
          "16110-246",
          "16110-247"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SARECYCLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "2059023",
          "2059029",
          "2059031",
          "2059033",
          "2059035",
          "2059037"
        ],
        "spl_id": [
          "4f9be4df-4e12-4f08-8e6f-cb07926ea5e6"
        ],
        "spl_set_id": [
          "b200957c-3004-4988-be97-9fd619a83649"
        ],
        "package_ndc": [
          "16110-245-30",
          "16110-246-30",
          "16110-247-30"
        ],
        "unii": [
          "36718856JR"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "SEYSARA",
          "active_ingredients": [
            {
              "name": "SARECYCLINE HYDROCHLORIDE",
              "strength": "EQ 100MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "SEYSARA",
          "active_ingredients": [
            {
              "name": "SARECYCLINE HYDROCHLORIDE",
              "strength": "EQ 150MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "SEYSARA",
          "active_ingredients": [
            {
              "name": "SARECYCLINE HYDROCHLORIDE",
              "strength": "EQ 60MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}