{
  "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": "2",
          "submission_status": "AP",
          "submission_status_date": "20220318",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "70574",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213433Orig1s002ltr.pdf",
              "date": "20220321",
              "type": "Letter"
            },
            {
              "id": "70701",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213433Orig1s002lbl.pdf",
              "date": "20220405",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20200826",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "64450",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213433Orig1s000ltr.pdf",
              "date": "20200831",
              "type": "Letter"
            },
            {
              "id": "64518",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213433s000lbl.pdf",
              "date": "20200904",
              "type": "Label"
            },
            {
              "id": "64756",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213433Orig1s000TOC.html",
              "date": "20200929",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20210819",
          "review_priority": "STANDARD",
          "submission_class_code": "S",
          "submission_class_code_description": "Supplement"
        }
      ],
      "application_number": "NDA213433",
      "sponsor_name": "SUN PHARM",
      "openfda": {
        "application_number": [
          "NDA213433"
        ],
        "brand_name": [
          "WINLEVI"
        ],
        "generic_name": [
          "CLASCOTERONE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-994"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CLASCOTERONE"
        ],
        "rxcui": [
          "2474344",
          "2474349"
        ],
        "spl_id": [
          "2abfc28a-6f85-d793-e063-6394a90a9490"
        ],
        "spl_set_id": [
          "1673a84b-7f5c-47ab-a99c-1e3db21a6a09"
        ],
        "package_ndc": [
          "47335-994-36",
          "47335-994-40",
          "47335-994-94"
        ],
        "nui": [
          "N0000000243",
          "N0000175560"
        ],
        "pharm_class_moa": [
          "Androgen Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Androgen Receptor Inhibitor [EPC]"
        ],
        "unii": [
          "XN7MM8XG2M"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "WINLEVI",
          "active_ingredients": [
            {
              "name": "CLASCOTERONE",
              "strength": "1%"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CREAM",
          "route": "TOPICAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}