{
  "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": "20121204",
          "application_docs": [
            {
              "id": "31489",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090704Orig1s000ltr.pdf",
              "date": "20121206",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20210513",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20150819",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20150819",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20210513",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA090704",
      "sponsor_name": "PHARMOBEDIENT",
      "openfda": {
        "application_number": [
          "ANDA090704"
        ],
        "brand_name": [
          "CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-3001",
          "0378-3002",
          "0378-3003"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CANDESARTAN CILEXETIL",
          "HYDROCHLOROTHIAZIDE"
        ],
        "rxcui": [
          "578325",
          "578330",
          "802749"
        ],
        "spl_id": [
          "b308024b-d9c2-4b12-ac28-cb2e295ab1bf"
        ],
        "spl_set_id": [
          "f3c4f7ed-e667-4528-a675-b032c2a4425d"
        ],
        "package_ndc": [
          "0378-3001-77",
          "0378-3002-77",
          "0378-3003-77"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "R85M2X0D68",
          "0J48LPH2TH"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE",
          "active_ingredients": [
            {
              "name": "CANDESARTAN CILEXETIL",
              "strength": "32MG"
            },
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "25MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE",
          "active_ingredients": [
            {
              "name": "CANDESARTAN CILEXETIL",
              "strength": "16MG"
            },
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "12.5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE",
          "active_ingredients": [
            {
              "name": "CANDESARTAN CILEXETIL",
              "strength": "32MG"
            },
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "12.5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}