{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20220128",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "70021",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210308Orig1s002ltr.pdf",
              "date": "20220201",
              "type": "Letter"
            },
            {
              "id": "70040",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210308s002lbl.pdf",
              "date": "20220201",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20260513",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "85917",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210308Orig1s010ltr.pdf",
              "date": "20260515",
              "type": "Letter"
            },
            {
              "id": "85937",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210308s010lbl.pdf",
              "date": "20260518",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20180522",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "54311",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210308s000lbl.pdf",
              "date": "20180523",
              "type": "Label"
            },
            {
              "id": "54328",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210308Orig1s000ltr.pdf",
              "date": "20180524",
              "type": "Letter"
            },
            {
              "id": "55868",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210308Orig1s000TOC.html",
              "date": "20181011",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20220324",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "70601",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210308Orig1s003ltr.pdf",
              "date": "20220325",
              "type": "Letter"
            },
            {
              "id": "70607",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210308s003lbl.pdf",
              "date": "20220325",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20200917",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64600",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210308Orig1s001ltr.pdf",
              "date": "20200918",
              "type": "Letter"
            },
            {
              "id": "64614",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210308s001lbl.pdf",
              "date": "20200918",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA210308",
      "sponsor_name": "SUN PHARM",
      "openfda": {
        "application_number": [
          "NDA210308"
        ],
        "brand_name": [
          "YONSA"
        ],
        "generic_name": [
          "ABIRATERONE ACETATE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-401"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ABIRATERONE ACETATE"
        ],
        "rxcui": [
          "2046579",
          "2046585"
        ],
        "spl_id": [
          "a43dcc9a-83c6-45eb-ab06-20ccc51306bd"
        ],
        "spl_set_id": [
          "b8967e10-f768-47ce-ac9e-2324c8390132"
        ],
        "package_ndc": [
          "47335-401-81"
        ],
        "unii": [
          "EM5OCB9YJ6"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "YONSA",
          "active_ingredients": [
            {
              "name": "ABIRATERONE ACETATE",
              "strength": "125MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}