{
  "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": "20240718",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA213300",
      "sponsor_name": "AUROBINDO PHARMA",
      "openfda": {
        "application_number": [
          "ANDA213300"
        ],
        "brand_name": [
          "DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "59651-063"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DUTASTERIDE",
          "TAMSULOSIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "996097"
        ],
        "spl_id": [
          "2ad47033-76f3-447d-8a44-21479e9164c0"
        ],
        "spl_set_id": [
          "2ad47033-76f3-447d-8a44-21479e9164c0"
        ],
        "package_ndc": [
          "59651-063-30",
          "59651-063-90"
        ],
        "nui": [
          "N0000175836",
          "N0000000126"
        ],
        "pharm_class_epc": [
          "5-alpha Reductase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "5-alpha Reductase Inhibitors [MoA]"
        ],
        "unii": [
          "O0J6XJN02I",
          "11SV1951MR"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "DUTASTERIDE",
              "strength": "0.5MG"
            },
            {
              "name": "TAMSULOSIN HYDROCHLORIDE",
              "strength": "0.4MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}