{
  "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": "4",
          "submission_status": "AP",
          "submission_status_date": "20260114",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20181204",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "57325",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208813Orig1s000TAltr.pdf",
              "date": "20190122",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "ANDA208813",
      "sponsor_name": "RISING",
      "openfda": {
        "application_number": [
          "ANDA208813"
        ],
        "brand_name": [
          "TOREMIFENE CITRATE"
        ],
        "generic_name": [
          "TOREMIFENE CITRATE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "64980-404"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TOREMIFENE CITRATE"
        ],
        "rxcui": [
          "313428"
        ],
        "spl_id": [
          "6aa927e6-a0b9-4904-aa11-e5a3f52cee47"
        ],
        "spl_set_id": [
          "dbde10d5-c689-428f-841d-b34aa5addf2d"
        ],
        "package_ndc": [
          "64980-404-03"
        ],
        "unii": [
          "2498Y783QT"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "TOREMIFENE CITRATE",
          "active_ingredients": [
            {
              "name": "TOREMIFENE CITRATE",
              "strength": "EQ 60MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}