{
  "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": "15",
          "submission_status": "AP",
          "submission_status_date": "20260414",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20251105",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20250221",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20240530",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20191101",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20260303",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20260414",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20190426",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "76402",
              "url": "https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=395",
              "date": "20231106",
              "type": "REMS"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20240917",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20220429",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS"
        }
      ],
      "application_number": "ANDA207760",
      "sponsor_name": "ZYDUS PHARMS",
      "openfda": {
        "application_number": [
          "ANDA207760"
        ],
        "brand_name": [
          "BOSENTAN"
        ],
        "generic_name": [
          "BOSENTAN"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc.",
          "Zydus Lifesciences Limited"
        ],
        "product_ndc": [
          "68382-446",
          "68382-447",
          "70771-1017",
          "70771-1018"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BOSENTAN"
        ],
        "rxcui": [
          "349253",
          "656659"
        ],
        "spl_id": [
          "f6180792-cb7a-46ef-b2bb-4a819e4901bb",
          "33935d05-c8ff-4d9e-91bf-fac9072d25fd"
        ],
        "spl_set_id": [
          "8444da17-6c31-492b-8842-93740f083d9d",
          "02892f47-0d59-4254-9ee7-d524278fdd79"
        ],
        "package_ndc": [
          "68382-446-14",
          "68382-446-01",
          "68382-446-28",
          "68382-446-05",
          "68382-446-30",
          "68382-446-77",
          "68382-447-14",
          "68382-447-01",
          "68382-447-28",
          "68382-447-05",
          "68382-447-30",
          "68382-447-77",
          "70771-1017-6",
          "70771-1017-1",
          "70771-1017-8",
          "70771-1017-5",
          "70771-1017-2",
          "70771-1017-4",
          "70771-1018-6",
          "70771-1018-1",
          "70771-1018-8",
          "70771-1018-5",
          "70771-1018-2",
          "70771-1018-4"
        ],
        "unii": [
          "Q326023R30"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "BOSENTAN",
          "active_ingredients": [
            {
              "name": "BOSENTAN",
              "strength": "62.5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "BOSENTAN",
          "active_ingredients": [
            {
              "name": "BOSENTAN",
              "strength": "125MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}