{
  "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": "3",
          "submission_status": "AP",
          "submission_status_date": "20150114",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20120830"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20181207",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20150114",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20220915",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA079060",
      "sponsor_name": "AUROBINDO PHARMA LTD",
      "openfda": {
        "application_number": [
          "ANDA079060"
        ],
        "brand_name": [
          "ALFUZOSIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "ALFUZOSIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited",
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "65862-249",
          "57237-114"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ALFUZOSIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "861132"
        ],
        "spl_id": [
          "d8c832c1-9455-4647-822a-ee4f35ba0560",
          "c759b18f-8985-4b41-852f-2aa423b32748"
        ],
        "spl_set_id": [
          "d163369b-e44b-4591-b166-7ddd0c1c13c0",
          "43675e9d-a361-4109-9ae1-54d80580fbbd"
        ],
        "package_ndc": [
          "65862-249-30",
          "65862-249-90",
          "65862-249-01",
          "65862-249-05",
          "65862-249-99",
          "57237-114-90",
          "57237-114-01",
          "57237-114-05"
        ],
        "unii": [
          "75046A1XTN"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "ALFUZOSIN HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "ALFUZOSIN HYDROCHLORIDE",
              "strength": "10MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}