{
  "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": "20161116",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 2/4",
          "submission_class_code_description": "Type 2 New Active Ingredient and Type 4 New Combination",
          "application_docs": [
            {
              "id": "45902",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208470s000lbl.pdf",
              "date": "20161116",
              "type": "Label"
            },
            {
              "id": "45905",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208470Orig1s000ltr.pdf",
              "date": "20161117",
              "type": "Letter"
            },
            {
              "id": "51046",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000TOC.html",
              "date": "20180112",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20180213",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "52624",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208470s001lbl.pdf",
              "date": "20180214",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA208470",
      "sponsor_name": "MILLICENT",
      "openfda": {
        "application_number": [
          "NDA208470"
        ],
        "brand_name": [
          "INTRAROSA"
        ],
        "generic_name": [
          "PRASTERONE"
        ],
        "manufacturer_name": [
          "Millicent US, Inc."
        ],
        "product_ndc": [
          "72495-401",
          "72495-501"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "VAGINAL"
        ],
        "substance_name": [
          "PRASTERONE"
        ],
        "rxcui": [
          "1927688",
          "1927693"
        ],
        "spl_id": [
          "2b9876fb-e9e0-4dbc-e063-6294a90a8696"
        ],
        "spl_set_id": [
          "ada639d4-bac0-2ad0-e053-2a95a90afce7"
        ],
        "package_ndc": [
          "72495-501-14",
          "72495-401-28"
        ],
        "unii": [
          "459AG36T1B"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "INTRAROSA",
          "active_ingredients": [
            {
              "name": "PRASTERONE",
              "strength": "6.5MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INSERT",
          "route": "VAGINAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}