{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20200529",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 4",
          "submission_class_code_description": "Type 4 - New Combination",
          "application_docs": [
            {
              "id": "63376",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213388s000lbl.pdf",
              "date": "20200602",
              "type": "Label"
            },
            {
              "id": "63387",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213388Orig1s000ltr.pdf",
              "date": "20200602",
              "type": "Letter"
            },
            {
              "id": "65154",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213388Orig1s000TOC.html",
              "date": "20201104",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20240730",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "79884",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213388Orig1s005ltr.pdf",
              "date": "20241015",
              "type": "Letter"
            },
            {
              "id": "79890",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213388Orig1s005lbl.pdf",
              "date": "20241015",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20230605",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "74439",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213388s003lbl.pdf",
              "date": "20230606",
              "type": "Label"
            },
            {
              "id": "74440",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213388s003lbl.pdf#page=29",
              "date": "20230606",
              "type": "Medication Guide"
            },
            {
              "id": "74444",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213388Orig1s003ltr.pdf",
              "date": "20230606",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20210802",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68275",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213388s001lbl.pdf",
              "date": "20210803",
              "type": "Label"
            },
            {
              "id": "68389",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213388Orig1s001ltr.pdf",
              "date": "20210817",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20251217",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84466",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213388Orig1s006ltr.pdf",
              "date": "20251219",
              "type": "Letter"
            },
            {
              "id": "85844",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213388s006lbl.pdf",
              "date": "20260507",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA213388",
      "sponsor_name": "ABBVIE",
      "openfda": {
        "application_number": [
          "NDA213388"
        ],
        "brand_name": [
          "ORIAHNN"
        ],
        "generic_name": [
          "ELAGOLIX AND ESTRADIOL AND NORETHISTERONE"
        ],
        "manufacturer_name": [
          "AbbVie Inc."
        ],
        "product_ndc": [
          "0074-1017"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "2371764",
          "2371766",
          "2371767",
          "2371768"
        ],
        "spl_id": [
          "92a6192f-7a2b-4bb7-be46-4664e07dcf44"
        ],
        "spl_set_id": [
          "99f6eee7-7e52-6999-7eb8-488d06dd1710"
        ],
        "package_ndc": [
          "0074-1017-56",
          "0074-1017-14"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ORIAHNN (COPACKAGED)",
          "active_ingredients": [
            {
              "name": "ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE",
              "strength": "EQ 300MG BASE,1MG,0.5MG"
            },
            {
              "name": "ELAGOLIX SODIUM",
              "strength": "EQ 300MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}